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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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 >Phase >Start Date >Summary

Clinical Trial Conditions for Desyrel

Condition Name

Condition Name for Desyrel
Intervention Trials
Healthy 3
Insomnia 2
Sleep Apnea, Obstructive 1
End Stage Renal Disease 1
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Condition MeSH

Condition MeSH for Desyrel
Intervention Trials
Sleep Wake Disorders 2
Parasomnias 2
Sleep Initiation and Maintenance Disorders 2
Mental Disorders 1
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Clinical Trial Locations for Desyrel

Trials by Country

Trials by Country for Desyrel
Location Trials
United States 5
Canada 2
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Trials by US State

Trials by US State for Desyrel
Location Trials
Rhode Island 2
Ohio 1
Connecticut 1
New York 1
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Clinical Trial Progress for Desyrel

Clinical Trial Phase

Clinical Trial Phase for Desyrel
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Desyrel
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 3
Withdrawn 1
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Clinical Trial Sponsors for Desyrel

Sponsor Name

Sponsor Name for Desyrel
Sponsor Trials
Labopharm Inc. 2
University of Washington 1
Algorithme Pharma Inc 1
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Sponsor Type

Sponsor Type for Desyrel
Sponsor Trials
Other 6
Industry 3
NIH 3
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