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NCT05328297 · ClinicalTrials.gov registry record · Phase 2
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
A Phase 2 study, sponsored by Janssen Pharmaceutica N.V., Belgium.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT05328297: Completed Phase 2 study, sponsored by Janssen Pharmaceutica N.V., Belgium.
NCT05328297 is a Phase 2 study that has completed, run by Janssen Pharmaceutica N.V., Belgium. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05328297, a Phase 2 study, has completed, sponsored by Janssen Pharmaceutica N.V., Belgium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
Primary Outcome
Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal
Interventions
- DRUG Placebo
- DRUG JNJ-55308942
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-06-03 |
| Est. Completion | 2024-05-17 |
| Phase | Phase 2 |
What the finished NCT05328297 record still lists
NCT05328297 is an interventional study that assigns participants to a tested intervention. The registered 116 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 (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05328297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05328297 about?
NCT05328297 is a clinical study titled "A Study of JNJ-55308942 in the Treatment of Bipolar Depression". The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
What is the current status of trial NCT05328297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2022-06-03. Estimated completion is 2024-05-17.
What interventions are being tested in trial NCT05328297?
The interventions under investigation include: Placebo (DRUG), JNJ-55308942 (DRUG).
Who is sponsoring clinical trial NCT05328297?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05328297's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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