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NCT01369095 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

A Phase 2 study of Depression, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
976
Enrollment target
20
Study locations

NCT01369095 is a Phase 2 study of Depression that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 976 participants, above the 785-participant average among 679 other Depression trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01369095, a Phase 2 study of Depression, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
976 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

Conditions Studied

Interventions

  • DRUG Duloxetine
  • DRUG Escitalopram
  • DRUG BMS-820836 Placebo
  • DRUG BMS-820836

Study Locations (20)

California

  • Catalina Research Institute, Llc - Chino
  • Behavioral Research Specialists, Llc - Glendale
  • Pacific Clinical Research Medical Group - Orange
  • Anderson Clinical Research - Redlands
  • Affiliated Research Institute - San Diego
  • Artemis Institute For Clinical Research - San Diego
  • Sharp Mesa Vista Hospital - San Diego

Florida

  • Meridien Research - Brooksville
  • Gulfcoast Clinical Research Center - Fort Myers
  • Amit Vijapura - Jacksonville
  • Stedman Clinical Trials - Tampa
  • Janus Center For Psychiatric Research - West Palm Beach

Alabama

  • Birmingham Psychiatry Pharmaceutical Studies, Inc. - Birmingham

Arkansas

  • Arkansas Psychiatric Clinic Clinical Research Trials, P.A. - Little Rock

Colorado

  • Western Affiliated Research Institute - Denver

Connecticut

  • Connecticut Clinical Research - Cromwell

Georgia

  • Emory University - Atlanta

Illinois

  • Uptown Research Institute, Llc - Chicago

Trial Details

FieldValue
Enrollment Target 976 participants
Start Date 2011-07
Est. Completion 2013-05
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01369095

The ClinicalTrials.gov registry entry for NCT01369095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 976 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 785-participant average among 679 other Depression trials with a reported enrollment target (24% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Duloxetine is the first listed.

NCT01369095 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT01369095 about?

NCT01369095 is a clinical study titled "Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression". The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

What is the current status of trial NCT01369095?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 976 participants. The study started on 2011-07. Estimated completion is 2013-05.

What conditions does trial NCT01369095 study?

This clinical trial studies the following conditions: Depression.

What interventions are being tested in trial NCT01369095?

The interventions under investigation include: Duloxetine (DRUG), Escitalopram (DRUG), BMS-820836 Placebo (DRUG), BMS-820836 (DRUG).

Who is sponsoring clinical trial NCT01369095?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01369095 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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

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.