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NCT03321526 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT03321526: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03321526 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03321526, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram \[mg\] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-months (24 weeks) treatment period, in participants with major depressive disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Primary Outcome
Time to all-cause discontinuation of study drug is defined as the number of days from the first dose of study drug to the last dose of study drug. Participants who completed double-blind treatment were not considered to have discontinued.
Interventions
- DRUG Quetiapine XR
- DRUG JNJ-42847922
- DRUG Placebo Matching to JNJ-42847922
- DRUG Placebo Matching to Quetiapine XR
- DRUG Selective Serotonin Reuptake Inhibitor (SSRI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2019-06-27 |
| Phase | Phase 2 |
What the finished NCT03321526 record still lists
NCT03321526 is an interventional study that assigns participants to a tested intervention. The registered 107 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 (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Quetiapine XR is the first listed.
NCT03321526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03321526 about?
NCT03321526 is a clinical study titled "A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy". The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram \[mg\] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause discontinuation of study drug...
What is the current status of trial NCT03321526?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2017-12-12. Estimated completion is 2019-06-27.
What interventions are being tested in trial NCT03321526?
The interventions under investigation include: Quetiapine XR (DRUG), JNJ-42847922 (DRUG), Placebo Matching to JNJ-42847922 (DRUG), Placebo Matching to Quetiapine XR (DRUG), Selective Serotonin Reuptake Inhibitor (SSRI) (DRUG).
Who is sponsoring clinical trial NCT03321526?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03321526's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 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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