CLINICAL TRIALS PROFILE FOR DESYREL
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All Clinical Trials for Desyrel
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00027053 ↗ | Trazodone for Sleep Disturbance in Early Alcohol Recovery | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 | 2002-06-01 | This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.) |
| NCT00027053 ↗ | Trazodone for Sleep Disturbance in Early Alcohol Recovery | Completed | Rhode Island Hospital | Phase 2 | 2002-06-01 | This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.) |
| NCT00253890 ↗ | Insomnia and Drug Relapse Risk | Completed | National Institute on Drug Abuse (NIDA) | Phase 3 | 2005-10-01 | The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance. |
| NCT00253890 ↗ | Insomnia and Drug Relapse Risk | Completed | Butler Hospital | Phase 3 | 2005-10-01 | The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance. |
| NCT00330291 ↗ | Xyrem for Treatment Refractory Insomnia Due to PTSD | Withdrawn | State University of New York - Upstate Medical University | Phase 2 | 2005-08-01 | Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population. |
| NCT00839072 ↗ | Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers | Completed | Algorithme Pharma Inc | Phase 1 | 2009-02-01 | The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations |
| NCT00839072 ↗ | Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers | Completed | Labopharm Inc. | Phase 1 | 2009-02-01 | The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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