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NCT03193398 · ClinicalTrials.gov registry record · Phase 2
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
A Phase 2 study, sponsored by BlackThorn Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT03193398: Completed Phase 2 study, sponsored by BlackThorn Therapeutics.
NCT03193398 is a Phase 2 study that has completed, run by BlackThorn Therapeutics. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03193398, a Phase 2 study, has completed, sponsored by BlackThorn Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
Primary Outcome
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34
Interventions
- DRUG BTRX-246040 oral capsule(s)
- DRUG Placebo oral capsule(s)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2018-12-12 |
| Phase | Phase 2 |
What the finished NCT03193398 record still lists
NCT03193398 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which BTRX-246040 oral capsule(s) is the first listed.
NCT03193398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03193398 about?
NCT03193398 is a clinical study titled "BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder". This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
What is the current status of trial NCT03193398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2017-06-12. Estimated completion is 2018-12-12.
What interventions are being tested in trial NCT03193398?
The interventions under investigation include: BTRX-246040 oral capsule(s) (DRUG), Placebo oral capsule(s) (DRUG).
Who is sponsoring clinical trial NCT03193398?
This trial is sponsored by BlackThorn Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03193398's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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