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NCT01428661 · ClinicalTrials.gov registry record · Phase 2
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
A Phase 2 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 507
- Enrollment target
NCT01428661: Completed Phase 2 study, sponsored by Vanda Pharmaceuticals.
NCT01428661 is a Phase 2 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 507 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (281% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01428661, a Phase 2 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 507 participants
- Enrollment target
Study 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.
Primary Outcome
Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.
Interventions
- DRUG placebo
- DRUG tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01428661 record still lists
NCT01428661 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (281% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01428661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01428661 about?
NCT01428661 is a clinical study titled "Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder". 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.
What is the current status of trial NCT01428661?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 507 participants. The study started on 2011-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01428661?
The interventions under investigation include: placebo (DRUG), tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01428661?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01428661's enrollment target sits among peer trials
507 69th of 2000 higher than 1,932 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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