Phase 3
N=507
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01428661 ↗Enrolled (actual)
507
Serious AEs
1.3%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) — -8.19; -7.83; -13.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tasimelteon (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) |
-8.19; -7.83; -13.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01428661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.