Trials / Completed
CompletedNCT03559192
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-67953964 | JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily. |
| DRUG | Placebo | Matching placebo will be administered as 2 capsules orally once daily. |
Timeline
- Start date
- 2018-07-16
- Primary completion
- 2020-05-06
- Completion
- 2020-05-06
- First posted
- 2018-06-18
- Last updated
- 2025-04-29
- Results posted
- 2023-06-26
Locations
53 sites across 6 countries: United States, Germany, Moldova, Russia, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03559192. Inclusion in this directory is not an endorsement.