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NCT02153502 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
A Phase 2 study of Depressive Disorder, Treatment-Resistant, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT02153502: Completed Phase 2 study of Depressive Disorder, Treatment-Resistant, sponsored by Avanir Pharmaceuticals.
NCT02153502 is a Phase 2 study of Depressive Disorder, Treatment-Resistant that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 206 participants, roughly in line with the 215-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153502, a Phase 2 study of Depressive Disorder, Treatment-Resistant, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.
Primary Outcome
The MADRS consists of 10 items, each rated based on the structured interview. The dimensions assessed in the MADRS are as follows: 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Each item is rated on a scale from 0 to 6. The MADRS total score is the sum of the scores for the 10 dimensions and can range from 0 to 60, with higher scores indic
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)
Study Locations (20)
California
- - Bellflower
- - Costa Mesa
- - Garden Grove
- - Lomita
- - Oceanside
- - Riverside
- - Santa Ana
- - Sherman Oaks
Florida
- - Bradenton
- - Jacksonville
- - Miami
- - Orange City
- - Orlando
Alabama
- - Birmingham
- - Birmingham
Colorado
- - Denver
Georgia
- - Decatur
Illinois
- - Hoffman Estates
Indiana
- - Valparaiso
Maryland
- - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT02153502 record still lists
NCT02153502 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 215-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target.
The record links to 1 condition, with Depressive Disorder, Treatment-Resistant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02153502 names 20 study sites across 8 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02153502 about?
NCT02153502 is a clinical study titled "Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment". The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of ...
What is the current status of trial NCT02153502?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2014-07. Estimated completion is 2016-02.
What conditions does trial NCT02153502 study?
This clinical trial studies the following conditions: Depressive Disorder, Treatment-Resistant.
What interventions are being tested in trial NCT02153502?
The interventions under investigation include: Placebo (DRUG), AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination) (DRUG).
Who is sponsoring clinical trial NCT02153502?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02153502 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Treatment-Resistant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02153502's enrollment target sits among peer trials
206 3rd of 9 higher than 7 of 9 other Depressive Disorder, Treatment-Resistant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Treatment-Resistant 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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