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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/NCT01369095




Registration number
NCT01369095
Ethics application status
Date submitted
7/06/2011
Date registered
8/06/2011
Date last updated
12/10/2015

Titles & IDs
Public title
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
Scientific title
A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).
Secondary ID [1] 0 0
2011-000778-71
Secondary ID [2] 0 0
CN162-007
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 - Duloxetine
Treatment: Drugs - Escitalopram
Treatment: Drugs - BMS-820836 Placebo
Treatment: Drugs - BMS-820836
Treatment: Drugs - BMS-820836
Treatment: Drugs - BMS-820836
Treatment: Drugs - BMS-820836

Active Comparator: Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo -

Experimental: Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo -

Experimental: Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo -

Experimental: Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo -

Experimental: Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo -


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

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

Treatment: Drugs: BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)

Treatment: Drugs: BMS-820836
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)

Treatment: Drugs: BMS-820836
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)

Treatment: Drugs: BMS-820836
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)

Treatment: Drugs: BMS-820836
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Timepoint [1] 0 0
Week 13
Secondary outcome [1] 0 0
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Timepoint [1] 0 0
Week 13

Eligibility
Key inclusion criteria
- Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)

- Patients must be able to understand the nature of the study, agree to comply with the
prescribed dosage regimens, report for regularly scheduled office visits, and
communicate to study personnel about adverse events and concomitant medication use.

- Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major
Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental
Disorders- Fourth Edition (Text Revision)[DSM IV TR] criteria. The current depressive
episode must be > 8 weeks in duration and < 3 years duration.

- In the current Major depressive disorder (MDD) episode, patients should report a
history of inadequate response to 1-3 adequate trials of antidepressant treatment.

- Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score =
18 at Screening and Baseline.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who report an inadequate response (less than 50% reduction in depressive
symptom severity) to more than three adequate trials of antidepressant treatments
during the current depressive episode.

- Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an
adequate duration in their current episode.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
976
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
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United States of America
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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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Indiana
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Louisiana
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Massachusetts
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New York
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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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Canada
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British Columbia
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Canada
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New Brunswick
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Ontario
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Dole
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Douai
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France
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Elancourt
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France
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Jonzac Cedex
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France
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Montpellier Cedex 5
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India
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Andhra Pradesh
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Gujarat
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Maharashtra
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Uttar Pradesh
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Chennai
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Pune
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Varanasi
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Pisa
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Roma
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Siena
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Ponce
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Greater London
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Middlesex
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United Kingdom
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West Midlands

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 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01369095
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/ct2/show/NCT01369095