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NCT02498392 · ClinicalTrials.gov registry record · Phase 2
An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
A Phase 2 study of Anxiety and Depressive Disorder, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT02498392: Completed Phase 2 study of Anxiety and Depressive Disorder, sponsored by Janssen Research & Development.
NCT02498392 is a Phase 2 study of Anxiety and Depressive Disorder that has completed, run by Janssen Research & Development. The registered enrollment target is 161 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498392, a Phase 2 study of Anxiety and Depressive Disorder, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
Primary Outcome
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression. Each of 17 items is rated by clinician on either 3-point (0-2) or 5-point (0-4) scale with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, higher score represents more severe condition.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG JNJ-42165279
Study Locations (20)
Other
- - Chisinau
- - Orenburg
- - Saint Petersburg
- - Saratov
- - Tomsk
- - Yekaterinburg
- - Alicante
- - Barcelona
- - Bilbao
- - Sant Boi de Llobregat
- - Zamora
- - Hlevakha
California
- - Costa Mesa
- - Oceanside
Florida
- - Miami
Massachusetts
- - Natick
New York
- - Cedarhurst
North Carolina
- - Raleigh
Pennsylvania
- - Allentown
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2015-10-07 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 2 |
What the finished NCT02498392 record still lists
NCT02498392 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02498392 names 20 study sites across 8 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02498392 about?
NCT02498392 is a clinical study titled "An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress". The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergi...
What is the current status of trial NCT02498392?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2015-10-07. Estimated completion is 2019-02-04.
What conditions does trial NCT02498392 study?
This clinical trial studies the following conditions: Anxiety, Depressive Disorder.
What interventions are being tested in trial NCT02498392?
The interventions under investigation include: Placebo (OTHER), JNJ-42165279 (DRUG).
Who is sponsoring clinical trial NCT02498392?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02498392 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02498392's enrollment target sits among peer trials
161 104th of 364 higher than 261 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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.
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