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COMPLETED 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

NCT02153502 · View on ClinicalTrials.gov ↗

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.

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

4 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avanir Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02153502 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02153502?

This trial is sponsored by Avanir Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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