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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2010-024371-12
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Secondary ID [2]
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CN162-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Long-term effects of BMS-820836 on blood pressure in patients with depression
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Assessment method [1]
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Timepoint [1]
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Baseline through Week 54
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Secondary outcome [1]
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• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
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Assessment method [1]
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Timepoint [1]
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Baseline through Week 54
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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
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2013
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Sample size
Target
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Accrual to date
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Final
789
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Brisbane
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Local Institution - Heidelberg
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Local Institution - Nedlands
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4000 - Brisbane
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5112 - Adelaide
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836
in patients with depression.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01361555
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01361555
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