Status:
COMPLETED
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
Detailed Description
This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive Disorder (MDD). T...
Eligibility Criteria
Inclusion
- Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;
- Current episode ≥4 weeks and ≤1 year;
- CGI-Severity score ≥4 at screening and baseline.
Exclusion
- Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;
- Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;
- A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;
- Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;
- Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT01428661
Start Date
September 1 2011
End Date
May 1 2013
Last Update
June 19 2015
Active Locations (40)
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1
Vanda Investigational Site
Garden Grove, California, United States, 92845
2
Vanda Investigational Site
Irvine, California, United States, 92617
3
Vanda Investigational Site
Los Alamitos, California, United States, 90720
4
Vanda Investigational Site
Oakland, California, United States, 94612