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NCT03446846 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder
A Phase 2 study, sponsored by Minerva Neurosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
NCT03446846: Completed Phase 2 study, sponsored by Minerva Neurosciences.
NCT03446846 is a Phase 2 study that has completed, run by Minerva Neurosciences. The registered enrollment target is 360 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446846, a Phase 2 study, has completed, sponsored by Minerva Neurosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
Study Summary
MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated, physician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe conditions. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude
Interventions
- DRUG Placebo
- DRUG MIN-117 5.0 mg
- DRUG MIN-117 2.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2019-12-13 |
| Phase | Phase 2 |
What the finished NCT03446846 record still lists
NCT03446846 is an interventional study that assigns participants to a tested intervention. The registered 360 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 (171% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03446846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03446846 about?
NCT03446846 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder". MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, inclu...
What is the current status of trial NCT03446846?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2018-03-30. Estimated completion is 2019-12-13.
What interventions are being tested in trial NCT03446846?
The interventions under investigation include: Placebo (DRUG), MIN-117 5.0 mg (DRUG), MIN-117 2.5 mg (DRUG).
Who is sponsoring clinical trial NCT03446846?
This trial is sponsored by Minerva Neurosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03446846's enrollment target sits among peer trials
360 123rd of 2000 higher than 1,874 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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