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

NCT01369095 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 976

Last updated 2015-10-12

No results posted yet for this 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

Interventions

DRUG

Duloxetine

Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)

DRUG

Escitalopram

Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)

DRUG

BMS-820836 Placebo

Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)

DRUG

BMS-820836

Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)

DRUG

BMS-820836

Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)

DRUG

BMS-820836

Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)

DRUG

BMS-820836

Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Canada
  • France
  • India
  • Italy
  • Puerto Rico
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369095 on ClinicalTrials.gov