Long-Term Use of Fanapt Explored in Phase I Study
A clinical study evaluating the long-acting injectable (or depot) formulation of Fanapt® (iloperidone) is now underway. The Phase I study will evaluate the safety and pharmacokinetic profiles of two different long-acting formulations of Fanapt in patients with schizophrenia.
Fanapt was approved by the U.S. Food and Drug Administration in 2009 for the acute treatment of adult patients with schizophrenia.
Source.“Vanda Pharmaceuticals Announces Commencement of Clinical Study of Long-Acting Injectable Formulation of Fanapt.” (2011, April 11). Retrieved May 25, 2011, from http://in.reuters.com/article/2011/04/11/idUS105442+11-Apr-2011+PRN20110411.
Clinical Trial of Tourette Syndrome Drug Underway
The national Tourette Syndrome Association (TSA) and Psyadon Pharmaceuticals Inc. have announced their collaboration on a clinical trial to determine the potential efficacy of a novel drug, ecopipam, for managing the symptoms of Tourette syndrome (TS). The TSA will also assist with study participant recruitment for the clinical trial.
Various off-label drugs are prescribed by medical professionals for TS, but of these, only two—pimozide (Orap®) and haloperidol (Haldol®)—are approved by the U.S. Food and Drug Administration (FDA) for the treatment of TS.
The FDA granted ecopipam an orphan-drug designation for the treatment of TS in September 2010. Experiments in animals suggest that ecopipam, a dopamine D1 antagonist, interacts with nerve cells and systems in the brain that are thought to contribute to the development of tics and other symptoms in TS.
The clinical trial, which has already begun, is a Phase IIa, open-label, nonrandomized trial to examine the ability of ecopipam to both reduce tic severity and determine its safety in individuals (ages 18 to 65) with TS. The study is being conducted at four sites across the United States and is expected to last for several months. Psyadon and TSA anticipate the data from this clinical trial will be released by mid-2012.
Source.“Tourette Syndrome Association and Psyadon Pharmaceuticals to Collaborate on a Drug Trial for Tourette Syndrome Treatment.” (2011, May 11). Retrieved May 25, 2011, from http://www.reuters.com/article/2011/05/11/idUS132568+11-May-2011+PRN20110511.
Residual Depression Symptoms Still Exist After SSRI Treatment
Even people who show a clear treatment response with antidepressant medications continue to experience symptoms such as insomnia, sadness, and decreased concentration, researchers have found after analyzing data from the largest study on the treatment of depression.
In the study, published in the Journal of Clinical Psychopharmacology, researchers tracked a wide range of symptoms of depression—including sadness, suicidal thoughts, and changes in sleep patterns, appetite/weight, concentration, outlook, and energy/fatigue—at the start of the trial and at the end of the antidepressant treatment course.
The study team used data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, the largest ever on the treatment of major depressive disorder and considered a benchmark in the field of depression research. The 6-year, National Institute of Mental Health-sponsored study initially included more than 4,000 patients with major depressive disorder from clinics across the country. All responders reported three to 13 residual depressive symptoms, and 75% of participants reported five or more symptoms.
Some of their symptoms included insomnia that occurs in the middle of the night (nearly 79%), sadness (nearly 71%), and decreased concentration and decision-making skills (nearly 70%). Moderately severe midnoctural insomnia was reported in nearly 60% of participants—more than twice as frequently as other symptoms. Thoughts of suicide rarely persisted or emerged during treatment, researchers found.
Researchers in the STAR*D trial found that only 33% of people go into remission in the first 12 weeks of treatment with a selective serotonin reuptake inhibitor (SSRI). Individuals taking SSRIs often still exhibit symptoms of depression. For one of first times, researchers sought with this analysis in a large sample to identify residual symptoms of the disease and whether these symptoms began before or during treatment. The researchers looked at data from the 2,876 STAR*D participants who completed the first phase of the trial—treatment with an SSRI for 12 weeks. Approximately 15% (n = 428) responded to treatment with no remission. Response was defined as a 50% decrease in severity of depression.
Source.“Widely Used Antidepressants May Not Do Enough to Improve All Symptoms of Depression.” (2011, April 21). Retrieved May 25, 2011, from http://www.newswise.com/articles/widely-used-antidepressants-may-not-do-enough-to-improve-all-symptoms-of-depression-ut-southwestern-researchers-find.