Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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