Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01361555

Enrollment

789

Registered

2011-05-27

Start date

2011-08-31

Completion date

2013-10-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Interventions

DRUGPlacebo matching with BMS-820836

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

DRUGBMS-820836

Tablet, Oral, 0.5 mg, Once daily, 54 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age) * Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study. * Patient not randomized in parent study that meet inadequate response criteria

Exclusion criteria

* Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam. * Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study \[including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)\]. * In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.

Design outcomes

Primary

Measure	Time frame
Long-term effects of BMS-820836 on blood pressure in patients with depression	Baseline through Week 54

Secondary

Measure	Time frame
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs	Baseline through Week 54

Countries

Argentina, Australia, Austria, Finland, France, India, Italy, Puerto Rico, South Africa, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026