Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Vermont
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Argentina
State/province [31] 0 0
Mendoza
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
Finland
State/province [34] 0 0
Jarvenpaa
Country [35] 0 0
Finland
State/province [35] 0 0
Oulu
Country [36] 0 0
Finland
State/province [36] 0 0
Seinajoki
Country [37] 0 0
Finland
State/province [37] 0 0
Tampere
Country [38] 0 0
Finland
State/province [38] 0 0
Turku
Country [39] 0 0
France
State/province [39] 0 0
Dole
Country [40] 0 0
France
State/province [40] 0 0
Douai
Country [41] 0 0
France
State/province [41] 0 0
Elancourt
Country [42] 0 0
France
State/province [42] 0 0
Jonzac
Country [43] 0 0
France
State/province [43] 0 0
Limoges Cedex
Country [44] 0 0
France
State/province [44] 0 0
Montpellier Cedex 5
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
India
State/province [46] 0 0
Gujarat
Country [47] 0 0
India
State/province [47] 0 0
Maharashtra
Country [48] 0 0
India
State/province [48] 0 0
Chennai
Country [49] 0 0
India
State/province [49] 0 0
Pune
Country [50] 0 0
India
State/province [50] 0 0
Varanasi
Country [51] 0 0
India
State/province [51] 0 0
Vishakapattanam
Country [52] 0 0
Italy
State/province [52] 0 0
Pisa
Country [53] 0 0
Italy
State/province [53] 0 0
Siena
Country [54] 0 0
Puerto Rico
State/province [54] 0 0
Ponce
Country [55] 0 0
South Africa
State/province [55] 0 0
Gauteng
Country [56] 0 0
South Africa
State/province [56] 0 0
Kwa Zulu Natal
Country [57] 0 0
South Africa
State/province [57] 0 0
Western Cape
Country [58] 0 0
Spain
State/province [58] 0 0
Arganda Del Rey
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Sweden
State/province [61] 0 0
Halmstad
Country [62] 0 0
Sweden
State/province [62] 0 0
Kungens Kurva
Country [63] 0 0
Sweden
State/province [63] 0 0
Lund
Country [64] 0 0
Sweden
State/province [64] 0 0
Uppsala

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01361555