Psychiatry Archive

Thursday, February 11, 2010

We See the Future: A World Without Quotient ADHD System

Here's an idea for a startup. Someone has to write an application for computers and game consoles that can ask kids to perform various tasks, watch them via a webcam, and help clinicians diagnose ADHD. Sure, product development and trials will cost millions, but the end result, say in the form of a friendly Wii game, should be more palatable than the monster on the right. Would you be able to sit still in front of the Quotient ADHD System from BioBehavioral Diagnostics Co., a Westford, Mass firm? We doubt it. Perhaps sticking a few strategically placed Dilbert cartoons on the walls of this system would help take the drab out of it. Regardless, this is the option currently available and if your office needs one then the fantasy Wii version is no competition for an existing system.

Here's more about the Quotient ADHD technology:

The Quotient™ ADHD System collects and reports objective, accurate data on hyperactivity, impulsivity and inattention. The clinician integrates the Quotient™ ADHD Test report with information from other assessment tools and the clinical evaluation to guide treatment decisions.

ADHD historically has been challenging to diagnose because many of the assessment tools rely largely on subjective information from parents and teachers, in addition to clinical evaluation.

The Quotient™ ADHD System accurately measures motion and analyzes shifts in attention state to give a clear picture of ADHD symptoms. The Quotient™ ADHD Test gives objective and accurate data on the core symptom areas of ADHD:

Hyperactivity (the inability to control movement and sit still while working)

Impulsivity (the inability to inhibit inappropriate responses)

Inattention (the difficulty in staying focused and on task)

1. Motion Tracking System
The Motion Tracking System captures each movement 50 times per second and plots the pattern of movement of the reflector(s).

2. Reflectors
A small reflector is placed on the forehead. If the patient is 13 years old or older, additional reflectors are placed on the shins to capture leg motion.

3. LCD Screen
The patient responds to different geometric shapes that flash randomly on the LCD screen

4. Keyboard
Patient responds to visual stimuli by pressing the space bar.

Product page: Quotient™ ADHD System...

MassDevice: BioBehavioral Diagnostics closes $7 million tranche in Series B round...

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Friday, January 22, 2010

Magnetoencephalography as An Objective Test for PTSD

Post-traumatic stress disorder (PTSD) can be a difficult condition to diagnose in patients that have difficulty "opening up" to a psychiatrist. Moreover, because symptoms of PTSD are often used as evidence in court cases, an objective test can be a welcome tool in helping to convict violent criminals. Now clinical researchers from the VA and University of Minnesota are reporting in the Journal of Neural Engineering that magnetoencephalography can provide an accurate analysis of the existence of PTSD in the brains of its victims.

From the University of Minnesota:

The researchers examined 74 veterans of conflicts in World War II, Vietnam, Iraq, or Afghanistan who had been diagnosed with PTSD, along with 250 healthy volunteers. Using a technique developed by [Apostolos Georgopoulos, Professor of Neuroscience and director of the Brain Sciences Center at the Minneapolis Veterans Affairs Medical Center], they monitored magnetic signals from groups of neurons in communication with each other.
They noted a pattern of miscommunication that was nearly unique to PTSD patients. Overall, they were able to identify people as PTSD patients or healthy controls with more than 90 percent accuracy.

"Compared to evidence from functional MRI and other diagnostic tools currently being accepted by courts for other disorders, this test is much stronger and has a higher probability of being accepted as evidence by courts," Georgopoulos says.

The pattern seen in PTSD patients appears to be a flaring up of brain networks that have to do with reliving experiences. Also, the strength of the pattern mirrored the severity of symptoms, suggesting that the test may be used to monitor a patient's progress during treatment.

A Minnesota Public Radio interview with Brian Engdahl, one of the authors of the study:

University of Minnesota statement: Researchers report first objective test for post-traumatic stress disorder...

Abstract in Journal of Neural Engineering: The synchronous neural interactions test as a functional neuromarker for post-traumatic stress disorder (PTSD): a robust classification method based on the bootstrap

Image: Magnetoencephalography machine from VSM MedTech

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Virtual Iraq Computer Simulator Helps Tackle Combat Induced PTSD

The US military is famous for employing emerging technologies to assist or replace its professionals on battlefields and beyond. As the wars in Iraq and Afghanistan continue, psychiatrists at the Department of Defense are now testing a virtual reality system as a therapy tool to address the causes of Post-Traumatic Stress Disorder (PTSD). Currently, psychiatrists use what is known as "exposure therapy" to have the soldiers repeatedly recall the events that led to the development of PTSD. Many of the soldiers, though, find it difficult to recall the events and to synthesize them in their imagination effectively during therapy sessions. To overcome this problem and to bring a bit of the original reality back, a program called Virtual Iraq is currently being trialed as an aid to traditional imagination based exposure therapy.

Army Medicine reports:

The congressionally-funded medical research study is the first randomized clinical trial that uses active-duty military diagnosed with combat-related PTSD to compare VRET results to traditional "imaginal" prolonged exposure therapy, and to a control group that waits five weeks for any type of treatment.
The study's sample size is 120 servicemembers to complete the three types of treatment options. Treatment sessions for each type of therapy last about 90 minutes, said Dr. Greg Reger, the chief of T2's Innovative Technology Applications division.

Patients undergoing VRET still explain to the therapist what happened that caused the trauma, but are exposed to a variety of computer-generated stimuli with the program "Virtual Iraq." VRET is designed to promote a multi-sensory emotional connection to the memory, thus helping the patient be able to gradually face the traumatic experiences that underlie his or her distressing memories after a number of treatment sessions.

This connection is facilitated by having the patient put on a head-mounted display (over-the-eyes video glasses) and either ride or drive in a simulated convoy, and Reger matches the scenario to the event. Or a Soldier will be given a dummy M-4 with a mounted game controller and conduct a dismounted patrol, and Reger could simulate gunfire.

Reger can customize the simulation experience ensuring ample control of the exposure to the programmed situations - changing weather conditions, terrain, helicopter flyovers, types of attack; even add in Muslim prayer call.

Press release: Virtual Reality Exposure Therapy to combat PTSD...

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Thursday, November 12, 2009

New Intel Device Helps Overcome Problems With Reading, Learning

Intel has released a new gadget for people with vision problems, autism, dyslexia, and other conditions that can make reading difficult. With the Intel Reader you can take pictures of book pages, letters, and product labels and the device will read out the text back while showing magnified print on the screen. While designed to be used by people with certain disabilities, we can also see using this device to learn how to read a new language.

The Intel Reader, about the size of a paperback book, converts printed text to digital text, and then reads it aloud to the user. Its unique design combines a high-resolution camera with the power of an Intel® Atom™ processor, allowing users to point, shoot and listen to printed text.

When the Intel Reader is used together with the Intel® Portable Capture Station, large amounts of text, such as a chapter or an entire book, can be easily captured for reading later. Users will have convenient and flexible access to a variety of printed materials, helping to not only increase their freedom, but improve their productivity and efficiency at school, work and home. The Intel Reader has been endorsed by the International Dyslexia Association as an important advance in assistive technology. Additionally, Intel is working with the Association of Assistive Technology Act Programs, the Council for Exceptional Children, Lighthouse International, the National Center for Learning Disabilities and the National Federation of the Blind to help reach and address the needs of people who have difficulty reading print.

Press release: Ready, Set, Read: Intel® Reader Transforms Printed Text to Spoken Word ...

Product page: Intel Reader ...

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Wednesday, October 21, 2009

Image Recognition Technology to Expand Abilities of Microsoft's Digital Camera Device

Microsoft has partnered with Oxford Metrics Group (Oxford, UK), a company specializing in computer vision applications, to further develop Microsoft's ViconRevue (formerly SenseCam) digital camera-like gadget. The device continuously snaps a picture every 30 seconds, hence it might be worn around the neck by patients with memory problems (i.e. Alzheimer's, s/p hypoxic/ischemic encephalopathy). The device is thought to help people refresh themselves on the activities of the past day. With Oxford Metrics Group's software built-in, the ViconRevue should be able to perform some pretty nifty tricks by recognizing objects and faces in its field of view.

Press release: IP LICENSE AGREEMENT WITH MICROSOFT...

Flashback: Digital Cameras for Dementia Patients

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Tuesday, October 20, 2009

Novel Product Design Aims to Address Common Autism Behavior

Some children with autism tend to perform compulsive rituals, and these can distract kids from the rest of the world. Jesse Resnick, a recent graduate of the product design program at Parsons the New School for Design, proposes a new toy-like device to grab kids' attention and limit compulsive behavior to a short time. The Repeat wrist worn device has flashing rubber knobs that blink in preprogrammed patterns, while the child follows along by using fingers to pinch them. According to the product page, Repeat is "an early-intervention tool for autistic children designed to replace repetitive behaviours (arm flapping, head banging, etc.) with a less distracting, less harmful alternative." It's not clear whether the benefit will be clinically valuable, but it does seem like a novel idea.

Product design page: REPEAT...

(hat tip: Yanko Design)

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Wednesday, September 23, 2009

Aspect Medical's Quantitative EEG Predicts Long Term Effectiveness of Anti Depression Medication

Aspect Medical Systems, maker of the bispectral index (BIS) monitor thought to be useful for monitoring anesthesia awareness, has been dealt a devastating blow last year by a study published in NEJM under the title Anesthesia Awareness and the Bispectral Index. The 2000 strong patient trial reported by Avidan, et al from Washington University School of Medicine in St. Louis has found the company's processed electroencephalogram technology is not essential "as part of standard practice."

Now Aspect Medical Systems is trying its hand in a new market: psychiatry. Finding an appropriate medication, as well as its dose, for a particular patient with bipolar disorder can take a good deal of time and is done without real quantitative tools. The clinical trial being reported by Aspect Medical is supposedly showing that the company's EEG-based system can be used to track whether a given SSRI (selective serotonin reuptake inhibitor, like Prozac or Paxil) is having positive results on a patient a week after initial doses were administered.

The BRITE trial was conducted in collaboration with leading investigators from nine facilities across the United States and enrolled 375 patients. Patient response was defined by researchers as a 50 percent improvement in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) after seven weeks of treatment, and remission was defined as recovery from depression (HAM-D <7) after seven weeks of treatment. In the BRITE study, ATR at one week predicted response and remission with 74 percent accuracy in subjects treated for seven weeks with escitalopram, which was statistically significant. Modeled study data also indicates that subjects who were ATR predicted non-responders to escitalopram had better outcomes if they were randomized to switch to bupropion, an antidepressant with a different mechanism of action than escitalopram.
Data from a study at Massachusetts General Hospital (MGH) investigating ATR as a predictor of treatment response was also recently published in European Neuropsychopharmacology. The MGH study evaluated ATR in 82 major depression patients receiving selective serotonin reuptake inhibitors (SSRI), and venlafaxine, and showed that use of ATR after the first week of antidepressant treatment may be predictive of treatment efficacy.

Continuing the ATR research effort, BRITE trial investigator Dr. Ian Cook at UCLA received a significant grant from the National Institutes of Mental Health to conduct a multi-year follow-on study of ATR called the PRISE-MD study (Personalized Response Indicators of SSRI Effectiveness in Major Depression). The PRISE-MD study will prospectively evaluate the ability of ATR to predict response to escitalopram as well as the clinical utility of ATR-directed treatment with escitalopram or an alternate treatment with bupropion.

Aspect Medical Systems press statement: Aspect Medical Systems Announces Publication of BRITE-MD Trial Results in Psychiatry Research...

More about the technology at Technology Review...

Abstract in Psychiatry Research: Comparative effectiveness of biomarkers and clinical indicators for predicting outcomes of SSRI treatment in Major Depressive Disorder: Results of the BRITE-MD study

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Wednesday, September 16, 2009

LENA Audio Monitor Analyses Speech Patterns to Help Detect Autism Earlier

Autistic children often show specific behavior patterns in the way they speak with others. These patterns, if detected, could be used as an early sign of autism, but enough data needs to be collected in order to help with making a diagnosis. LENA, a device from the LENA Foundation that became available earlier this month, is a portable recorder that can make available a day's worth of a child's interaction to professionals for close review.

From the product page:

What is LENA? LENA is the only technology that automatically collects and analyzes information about a child’s natural language environment and development. The LENA feedback reports help parents improve a child’s cumulative language experience and accelerate that child’s language and cognitive development, and preparedness for school.
Who is LENA for? Parents and caregivers of children ages 0 to 4.

Why is it important? Several hundred research studies over the last 50 years document the importance of talking to and interacting with your baby, especially during the first three years. Groundbreaking research by two renowned university researchers, Drs. Betty Hart, Ph.D., and Todd Risley, Ph.D., revealed that the quantity of talk a child experienced between birth and age 3 directly correlated with the child’s IQ and vocabulary size. The LENA Foundation was founded based on the key elements of this study and our own normative study shows that saying 17,000 words per day, which is equal to the 85th percentile, will greatly enhance your child’s potential.

Who developed it? A team of world-class scientists, including experts in linguistics, speech recognition technology, computer engineering, speech analysis, statistics, speech language pathology, language research and developmental pediatrics. Recognizing that achievement gaps already exist at kindergarten entry, LENA was developed to give parents useful information to help ensure they are providing the richest language environment possible to their children during the critical years between birth and age 4, before they enter school.

How does it work? Parents follow a simple three-step process, 2-3 times a month:

1. In the morning, slip the LENA Digital Language Processor (DLP) into the pocket of specially designed LENA clothing.
2. At the end of the day, plug the DLP into your PC. The audio data will transfer and software analysis begins.
3. View your reports to analyze your conversations, identify patterns of talk throughout the day and receive percentile rank information.

MIT Technology Review provides additional details:

Richards [Jeffrey Richards, a statistician and database technician for the LENA Foundation --ed.] says the LENABaby software, which he helped develop, starts by breaking down the 16-hour audio stream into segments. Each segment is automatically classified according to the type of sound contained in the clip, such as sounds from the child, a parent, or television. Vocalizations from the child are then assessed further using complex algorithms that look at a variety of factors, such as the phonological composition of the each sound and how sounds are clustered and paired. "We're simultaneously looking across many dimensions at the same time," says Richards. Using LENA's database of previously analyzed audio, the software considers how these characteristics compare to those of children developing normally, children with delayed language development, and autistic children.
LENABaby can be used for more than a basic diagnosis, helping to track a child's language development. This could make it a valuable tool for clinicians who otherwise have to rely on data collected during brief, infrequent visits.

Tuesday, September 8, 2009

Brainsway's Transcranial Magnetic Stimulation Gets European Regulatory Approval for Treatment of Depression

Brainsway, a firm building transcranial magnetic stimulation systems (TMS) out of Jerusalem, Israel, just received European approval to market its devices for the treatment of depression. The TMS treatment is likely to be used initially for cases of severe drug resistant depression. But we can envision a day when this technology becomes a mainstream therapeutic option for bipolar disorder and some other psychiatric diseases.

About the technology from Brainsway:

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.
Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

Globes Online: Brainsway depression treatment gets European OK...

Product page: Brainsway Deep TMS System...

Flashbacks: Brainsway TMS archives...

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Tuesday, September 1, 2009

rethink autism Online Platform for Autism Therapy at Home

Therapy sessions for autistic kids are not only expensive, but can also present a daunting challenge that typically involves going to an unfamiliar clinical environment. To help parents and caretakers work directly with kids in their own home, rethink autism online training application has been developed. According to the company with the same name, the application is based on applied behavior analysis (ABA) techniques. By offering video demonstrations of effective therapeutic approaches, coupled with a platform for development of personalized lesson plans, rethink autism may serve as a complement to existing therapy sessions as well as an effective option for those without access to professionals.

Here's a company introduction to the rethink autism program:

Link: rethink autism

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Monday, August 31, 2009

orbiTouch Keyboard Helps Autistic Kids Get The Word Out

Computers can provide a layer of separation that can be helpful to interacting with autistic kids, consequently they have become a popular tool for one on one therapy sessions. The keyboard, though, can be too confusing and difficult to use and can itself become an obstacle to communication. And since autistic kids tend to be visual learners, a new project that uses a different type of keyboard is helping kids learn to communicate with their families and therapists. The orbiTouch from Blue Orb (Maitland, Florida) is a keyboard, originally developed for people with bad hands , that sports two controllers that, with the help of a color chart, let the user select which letter is to be typed.

The National Science Foundation reports on Project Blue Skies:

With Project Blue Skies, the hardware is matched to lesson plans, training aids such as games, and assessment tools. The two-grip device is ideal for people with autism because it is less distracting than a keyboard and does not require finger motion.
In addition, the various letter and number combinations are created by matching color schemes indicated on the two grips, so the training curriculum matches well to a game-like environment.

Teachers guide the students and monitor their progress, ultimately helping the kids better communicate with their families. While the primary goal of Project Blue Skies is to help people with autism develop stronger social skills, McAlindon [Pete McAlindon of BlueOrb] is working with partners to start integrating standard coursework into the program.

Press release: Removing the Barriers of Autism

Link: Project Blue Skies

Product page: orbiTouch Keyless Ergonomic Keyboard

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Friday, August 7, 2009

VA to Trial Transcranial Magnetic Stimulation for ADD

Israeli business newspaper Globes is reporting that the U.S. Department of Veterans Affairs has signed an agreement with Brainsway, a Jerusalem company profiled by us many times before, to trial the firm's deep transcranial magnetic stimulation (TMS) device on twenty patients with attention deficit disorder. Experts believe that TMS technology might become increasingly useful as a new way to treat a variety of psychiatric and neurological problems, such as bipolar disorder, cocaine or nicotine addiction, or even as a treatment for symptoms of Parkinson's and multiple sclerosis.

More about the upcoming trial from Globes...

Flashbacks: Brainsway to Test TMS for Smoking Cessation; Magnetic Brain Stimulation for Cocaine Addiction, Multiple Sclerosis?; Neuronetics TMS Depression Therapy Gets FDA OK; Experiencing Transcranial Magnetic Stimulation; Positive Results Reported for Deep TMS H System For Depression; Deep TMS Technology by Brainsway

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Wednesday, July 8, 2009

Think Your Own Music Outloud

You know that tune you hum to yourself in your head? Or maybe that song that is stuck in your brain? Now, thanks to MRI researchers, you can play that for everyone around you. Dan Loyd and researchers at Trinity College have developed a media player for your brain.

Using MRI images to study active parts of the brain during various tasks or thoughts, pitches are asigned to different regions. These are then used to generate notes played at varying intensities to match the intensity of the active brain region.

While this may seem fun and whimsical, the motivation for this work is much more serious. Lloyd is comparing scans of volunteers with dementia and schizophrenia patients to gain insight into unlocking the mysteries of these conditions.

New Scientist : Eavesdropping on the music of the brain

Trinity College: Dan Lloyd

(hat tip to Gizmodo)

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Tuesday, July 7, 2009

Coming Soon: Online Treatment for Insomnia

Researchers from the University of Virginia Health System conducted a study of an internet based intervention program designed to help people suffering from insomnia. The cleverly named SHUTi (Sleep Healthy Using the Internet) online app offers clinical outcomes that seem to be as good or even better than those achieved with personalized treatments offered by therapists. Here's one of the lead members of the research team speaking about the study:

JAMA/Archives Media Relations Dept weights in:: Internet-Based Intervention May Improve Insomnia...

Abstract in Archives of General Psychiatry: Efficacy of an Internet-Based Behavioral Intervention for Adults With Insomnia Arch Gen Psychiatry. 2009;66(7):692-698.

S H U T i...

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Wednesday, July 1, 2009

Brainsway to Test TMS for Smoking Cessation

Brainsway Ltd. out of Jerusalem, Israel, a company we've been covering over the last few years, has received local approval to conduct clinical trials of its deep transcranial magnetic stimulation (TMS) as an aid in quitting smoking. The drastic approach is to be tested on about 100 lung cancer patients that have not been able to quit using other methods.

Tuesday, June 2, 2009

PlayStation May Help Burn Victims Adjust to New Reality

Following severe injury or reconstructive surgery that considerably alters patient's visual appearance, many people suffer from psychological issues trying to adjust to the new reality. Becoming comfortable with oneself and having a good impression of how one looks to others can greatly improve self esteem and help move on with life. To aid and accelerate this process, Dr. Joseph Haik, a plastic surgeon and burn specialist at Tel Aviv University and director of the Chaim Sheba Medical Center-Tel Hashomer Hospital's Burn Unit, has been recommending the EyeToy accessory for the Sony PlayStation to many of his patients. The EyeToy uses a camera atop a television to place a player inside the game he's playing. By seeing oneself in action in the game, Dr. Haik believes patients can get more comfortable with their new exterior.

Here's a video giving a good idea of what an EyeToy game looks like:

Thursday, May 21, 2009

Libra DBS Showing More Promise in Study

St. Jude Medical has released results of a Canadian study evaluating the effectiveness of the firm's deep brain stimulation (DBS) system for treatment of drug resistant depression. The device is designed to send electrical signals to the Brodmann Area of the brain via implanted electrodes, a modality that looks more and more promising to alleviate symptoms in patients with advanced depression.

This study profiles 21 patients with DBS therapy in the area of the brain known as Brodmann Area 25, most of whom have completed one year of post-surgery evaluation. At six months, 62 percent of the patients experienced at least a 40-percent decrease in symptoms of depression as measured by a standardized test called the Hamilton Rating Scale for Depression. Of these patients, 92 percent maintained this improvement at their last follow-up visit (typically at one year). Additionally, 71 percent of all patients in the study exhibited at least a 40-percent decrease in symptoms of depression as measured by the Hamilton scale.
Ongoing at three leading Canadian academic medical centers, the study utilizes the St. Jude Medical Libra® Deep Brain Stimulation System to deliver stimulation to an area of the brain known as Brodmann Area 25, which appears to become overactive in severely depressed people.

Patients in the study had suffered from depression for an average of 20 years, had tried in excess of 12 depression medications and were considered disabled or unable to work at the time of enrollment. At the 12-month evaluation point, eight of the study patients had returned to daily life activities such as school, work and sustaining relationships with family and friends, and two patients were considered to be in remission.

Press release: Patients in St. Jude Medical Deep Brain Stimulation for Depression Pilot Study Demonstrate Sustained Improvement in Depression Symptoms

Flashbacks: St. Jude Receives Patent for Anti Depression Neurostimulation Method; St. Jude Begins Trial of Deep Brain Stimulation for Depression; European Union Approves Deep Brain Stimulation Systems for Parkinson's; Libra DBS for Parkinson's Going Live in Europe

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Monday, April 27, 2009

Magnetic Brain Stimulation for Cocaine Addiction, Multiple Sclerosis?

Brainsway Inc., a Jerusalem, Israel firm that develops deep transcranial magnetic stimulation (TMS) machines, has announced receiving approval from the US National Institute on Drug Abuse (NIDA) to conduct a trial of its product to test whether the system can be used to treat cocaine addicted patients. Additionally, the company plans to test its device in a Berlin hospital as a treatment option for people with symptomatic multiple sclerosis.

About TMS therapy from Brainsway:

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.
Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

The unique technology of Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures.

Deep TMS is a breakthrough in the search for a non-invasive approach for treating common brain disorders. Deep TMS uses a unique, patented coil design to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, no systemic effect (in contrast to drugs), and no need of hospitalization or anesthesia.

Wednesday, March 18, 2009

Heavy Hydrogen Promises Better Versions of Current Drugs

Deuterium, a hydrogen atom with an extra neutron in the nucleus, has the property of forming stronger bonds with other atoms. It turns out that by replacing hydrogen atoms with deuterium in drug molecules, it is possible to improve the pharmacodynamic and even pharmacokinetic profiles of some drugs.

The field of pharmacologic deuteration is so promising that new companies are springing up, ready to convert already successful meds into deuterated drugs. Take for example Auspex Pharmaceuticals, a Vista, CA startup. The company reports that it has close to 50 drug candidates in its pipeline, including propanolol, simvastatin, and azythromycin. (Here''s a compelete list of product candidates from Auspex.)

The other company developing deuterated compounds is Concert Pharmaceuticals, Inc. from Lexington, Mass., which just announced positive results from Phase I clinical study of its CTP-347 drug, "an investigational non-hormonal treatment for vasomotor symptoms (hot flashes)." It turns out that CTP-347 is none other than a Prozac (Paroxetine) version ready to be deployed in thermonuclear weapons, thanks to its ²H modification of the Paroxetine molecule.

Here's what Concert Pharmaceuticals says about the results of the trial:

CTP-347, a novel deuterium-modified analog of paroxetine discovered at Concert, was well-tolerated at all doses. Paroxetine is a serotonin reuptake inhibitor that has been shown to reduce vasomotor symptoms. However, paroxetine inactivates the important liver enzyme CYP2D6 which can lead to serious side effects when used in combination with many common medications. In contrast, in this study, CTP-347 substantially retained the activity of this key enzyme, potentially enabling its broader use with other drugs. These clinical results confirm Concert’s preclinical observations. The Company expects to present the complete Phase 1 results at a future medical meeting in 2009.
“After our encouraging preclinical findings with CTP-347, we were pleased to see a consistent deuterium effect in a clinical setting,” stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “In preclinical studies, Concert has shown that selective deuterium substitution can improve the metabolic fate of drugs across a variety of parameters. This study addresses one important parameter and supports our belief that deuterium technology has great potential for rapidly creating best-in-class medicines with reduced risk.”

The Phase 1 clinical trial was a randomized, single-blind, placebo-controlled, ascending single- and multiple-dose study in 94 healthy volunteers. The primary objective of the study was to evaluate the safety, tolerability and pharmacokinetics of CTP-347. In this trial, CTP-347 was well-tolerated at all doses evaluated; there were no clinically significant adverse events reported and the pharmacokinetics were consistent with those observed in preclinical studies. As part of the multi-dose phase of the study, the extent to which CTP-347 inhibits the drug-metabolizing enzyme, CYP2D6, was evaluated by co-dosing subjects with dextromethorphan, which is metabolized by CYP2D6. In this portion of the study, women dosed with CTP-347 substantially retained their ability to metabolize dextromethorphan, suggesting that time-dependent inactivation of CYP2D6 was not observed with CTP-347 and indicating that CTP-347 may have a reduced potential for drug-drug interactions.

Press release from Concert Pharma: Concert Pharmaceuticals Announces Positive Results from Phase I Clinical Study of CTP-347; Concert Pharmaceuticals website...

Press release from Auspex Pharma: Positive Results From Clinical Study Of SD-254 (.pdf)... ; Auspex Pharmaceuticals website...

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