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NCT03093025 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
A Phase 2 study, sponsored by Taisho Pharmaceutical R&D.
- Terminated
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT03093025: Clinical Trial Phase 2 study, sponsored by Taisho Pharmaceutical R&D.
NCT03093025 is a Phase 2 study that was terminated before completion, run by Taisho Pharmaceutical R&D. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03093025, a Phase 2 study, was terminated before completion, sponsored by Taisho Pharmaceutical R&D.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).
Primary Outcome
The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). The total score is the sum of 10 items and can take range from 0 to 60. A negative change from baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG TS-121 10 mg
- DRUG TS-121 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-07-03 |
| Est. Completion | 2018-12-04 |
| Phase | Phase 2 |
Why NCT03093025 stopped before completion
NCT03093025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03093025 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03093025 about?
NCT03093025 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder". The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).
What is the current status of trial NCT03093025?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-07-03. Estimated completion is 2018-12-04.
What interventions are being tested in trial NCT03093025?
The interventions under investigation include: Placebo (DRUG), TS-121 10 mg (DRUG), TS-121 50 mg (DRUG).
Who is sponsoring clinical trial NCT03093025?
This trial is sponsored by Taisho Pharmaceutical R&D, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03093025's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 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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