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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01428661

Run by

Vanda Pharmaceuticals

People needed

507

Starts

2011-09-01

Expected to finish

2013-05-01

Last updated by the study team

2015-06-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Vanda Investigational Site — Garden Grove, California, United States
• Vanda Investigational Site — Irvine, California, United States
• Vanda Investigational Site — Los Alamitos, California, United States
• Vanda Investigational Site — Oakland, California, United States
• Vanda Investigational Site — Oceanside, California, United States
• Vanda Investigational Site — San Diego, California, United States
• Vanda Investigational Site — Sherman Oaks, California, United States
• Vanda Investigational Site — Torrance, California, United States
• Vanda Investigational Site — Denver, Colorado, United States
• Vanda Investigational Site — Bradenton, Florida, United States
• Vanda Investigational Site — Jacksonville, Florida, United States
• Vanda Investigational Site — Maitland, Florida, United States
• Vanda Investigational Site — North Miami, Florida, United States
• Vanda Investigational Site — Orlando, Florida, United States
• Vanda Investigational Site — Atlanta, Georgia, United States
• Vanda Investigational Site — Atlanta, Georgia, United States
• Vanda Investigational Site — Chicago, Illinois, United States
• Vanda Investigational Site — Joliet, Illinois, United States
• Vanda Investigational Site — Prairie Village, Kansas, United States
• Vanda Investigational Site — Baltimore, Maryland, United States
• Vanda Investigational Site — Boston, Massachusetts, United States
• Vanda Investigational Site — Omaha, Nebraska, United States
• Vanda Investigational Site — Las Vegas, Nevada, United States
• Vanda Investigational Site — Toms River, New Jersey, United States
• Vanda Investigational Site — Willingboro, New Jersey, United States

Full record on ClinicalTrials.gov

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