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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01361555




Registration number
NCT01361555
Ethics application status
Date submitted
25/05/2011
Date registered
27/05/2011
Date last updated
12/10/2015

Titles & IDs
Public title
Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
Scientific title
A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
Secondary ID [1] 0 0
2010-024371-12
Secondary ID [2] 0 0
CN162-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo matching with BMS-820836
Treatment: Drugs - BMS-820836
Treatment: Drugs - BMS-820836
Treatment: Drugs - BMS-820836

Experimental: Arm 1: Placebo + BMS-820836 (0.5 mg/day) -

Experimental: Arm 2: Placebo + BMS-820836 (1 mg/day) -

Experimental: Arm 3: Placebo + BMS-820836 (2 mg/day) -


Treatment: Drugs: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks

Treatment: Drugs: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks

Treatment: Drugs: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks

Treatment: Drugs: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term effects of BMS-820836 on blood pressure in patients with depression
Timepoint [1] 0 0
Baseline through Week 54
Secondary outcome [1] 0 0
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
Timepoint [1] 0 0
Baseline through Week 54

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
789
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Brisbane
Recruitment hospital [2] 0 0
Local Institution - Adelaide
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
5112 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Massachusetts
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New Mexico
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New York
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North Carolina
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Oklahoma
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Rhode Island
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Tennessee
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Texas
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Utah
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Vermont
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mendoza
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Austria
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Wien
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Helsinki
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Jarvenpaa
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Oulu
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Seinajoki
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Tampere
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Turku
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Dole
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France
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Douai
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Elancourt
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Jonzac
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Paris
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Gujarat
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Maharashtra
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Chennai
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Pune
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Varanasi
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India
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Vishakapattanam
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Italy
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Pisa
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Italy
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Siena
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Ponce
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Gauteng
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Kwa Zulu Natal
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Western Cape
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Spain
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Arganda Del Rey
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Spain
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Barcelona
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Madrid
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Sweden
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Halmstad
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Sweden
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Kungens Kurva
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Lund
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Sweden
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Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
Trial website
https://clinicaltrials.gov/study/NCT01361555
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01361555