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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 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.

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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.

Conditions Studied

Depressive Disorder, Treatment-Resistant

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

FieldValue
Enrollment Target 206 participants
Start Date 2014-07
Est. Completion 2016-02
Phase Phase 2

Sponsor

Avanir Pharmaceuticals

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02153502

The ClinicalTrials.gov registry entry for NCT02153502 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 215-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target. The listed sponsor is Avanir Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.