A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression
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- STATUS
- Recruiting
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- End date
- May 22, 2024
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- participants needed
- 164
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- sponsor
- Janssen Pharmaceutica N.V., Belgium
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.
Description
JNJ-55308942 is a potent, selective, and brain penetrant antagonist of the adenosine triphosphate (ATP) gated P2X7 receptor. The primary hypothesis that will be tested in this study is that JNJ-55308942, compared to placebo, results in a significant improvement in the reduction of the symptoms of depression in participants with BD in a MDE as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Efficacy assessment will include MADRS and safety assessment will include physical examination, electrocardiogram (ECG), vital signs, clinical safety laboratory assessments, and suicidal ideation and behavior risk monitoring. Total duration of this study will be up to 15 weeks.
Details
| Condition | Bipolar Disorder |
|---|---|
| Treatment | Placebo, JNJ-55308942 |
| Clinical Study Identifier | NCT05328297 |
| Sponsor | Janssen Pharmaceutica N.V., Belgium |
| Last Modified on | 23 October 2022 |
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