Efficacy and Safety of Fixed Doses of BMS 820836 in the T... | NCT01369095

Studies
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

NCT01369095

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

976Actual

Phase

Phase 2

Conditions

Depression

Interventions

Duloxetine
Escitalopram
BMS-820836 Placebo
BMS-820836
BMS-820836
BMS-820836
BMS-820836

Countries

United States
Argentina
Australia
Austria
Canada
France
India
Italy
Puerto Rico
South Africa
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2011-000778-71	EudraCT Number

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 7, 2011

First Posted Date

Jun 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 23, 2015

Certification/Extension First Submitted that Passed QC Review

Sep 23, 2015

Certification/Extension First Posted Date

Oct 12, 2015Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

976Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo	Active Comparator	Drug: Duloxetine Drug: Escitalopram Drug: BMS-820836 Placebo
Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo	Experimental	Drug: BMS-820836 Placebo Drug: BMS-820836
Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo	Experimental	Drug: BMS-820836 Placebo Drug: BMS-820836
Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo	Experimental	Drug: BMS-820836 Placebo Drug: BMS-820836
Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo	Experimental	Drug: BMS-820836 Placebo Drug: BMS-820836

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)	Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score		Week 13

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.		Week 13

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Psychiatry Pharmaceutical Studies, Inc.		Birmingham	Alabama	35226	United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D000068736	Duloxetine Hydrochloride
D000089983	Escitalopram
C000594001	6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011437	Propylamines
D000588	Amines
D009570	Nitriles
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring