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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01369095

Collaborator

(none)

976

Enrollment

Locations

Arms

Duration (Months)

10.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Duloxetine Drug: Escitalopram Drug: BMS-820836 Placebo Drug: BMS-820836 Drug: BMS-820836 Drug: BMS-820836 Drug: BMS-820836	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

976 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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).

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo	Drug: Duloxetine Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D) Other Names: Cymbalta Drug: Escitalopram Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D) Other Names: Lexapro Drug: BMS-820836 Placebo Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Experimental: Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C) Drug: BMS-820836 Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Experimental: Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C) Drug: BMS-820836 Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C) Drug: BMS-820836 Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C) Drug: BMS-820836 Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

Outcome Measures

Primary Outcome Measures

Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score [Week 13]

Secondary Outcome Measures

Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. [Week 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama	United States	35226
2	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas	United States	72223
3	Catalina Research Institute, Llc	Chino	California	United States	91710
4	Behavioral Research Specialists, Llc	Glendale	California	United States	91206
5	Pacific Clinical Research Medical Group	Orange	California	United States	92868
6	Anderson Clinical Research	Redlands	California	United States	92374
7	Affiliated Research Institute	San Diego	California	United States	92108
8	Artemis Institute For Clinical Research	San Diego	California	United States	92123
9	Sharp Mesa Vista Hospital	San Diego	California	United States	92123
10	Western Affiliated Research Institute	Denver	Colorado	United States	80209
11	Connecticut Clinical Research	Cromwell	Connecticut	United States	06416
12	Meridien Research	Brooksville	Florida	United States	34601
13	Gulfcoast Clinical Research Center	Fort Myers	Florida	United States	33912
14	Amit Vijapura	Jacksonville	Florida	United States	32256
15	Stedman Clinical Trials	Tampa	Florida	United States	33613
16	Janus Center For Psychiatric Research	West Palm Beach	Florida	United States	33407
17	Emory University	Atlanta	Georgia	United States	30306
18	Uptown Research Institute, Llc	Chicago	Illinois	United States	60640
19	Clinco	Terre Haute	Indiana	United States	47802
20	Clinical Trials Technology, Inc	Prairie Village	Kansas	United States	66206
21	Ert	Shreveport	Louisiana	United States	71104
22	Mclean Hospital	Belmont	Massachusetts	United States	02478
23	Bio Behavioral Health	Toms River	New Jersey	United States	08755
24	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico	United States	87109
25	Comprehensive Clinical Development, Inc	Fresh Meadows	New York	United States	11366
26	Bioscience Research, Llc	Mount Kisco	New York	United States	10549
27	Village Clinical Research, Inc.	New York	New York	United States	10003
28	Northcoast Clinical Trials, Inc	Beachwood	Ohio	United States	44122
29	Patient Priority Clinical Sites, Llc	Cincinnati	Ohio	United States	45215
30	Neurology & Neuroscience Center Of Ohio	Toledo	Ohio	United States	43623
31	Suburban Research Associates	Media	Pennsylvania	United States	19063
32	Keystone Clinical Studies, Llc	Norristown	Pennsylvania	United States	19403
33	Ert	Pittsburgh	Pennsylvania	United States	15219
34	Neuropsychiatric Research Center Of Orange County	Pittsburgh	Pennsylvania	United States	15219
35	Northwest Clinical Research Center	Pittsburgh	Pennsylvania	United States	15219
36	Lincoln Research	Lincoln	Rhode Island	United States	02865
37	Future Search Trials	Austin	Texas	United States	78731
38	Futuresearch Trials Of Dallas	Dallas	Texas	United States	75231
39	Insite Clinical Research	Desoto	Texas	United States	75115
40	Ben Taub General Hospital	Houston	Texas	United States	77030
41	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
42	Ericksen Research And Development	Clinton	Utah	United States	84015
43	Clinical Methods Llc	Murray	Utah	United States	84107
44	Neuropsychiatric Associates	Woodstock	Vermont	United States	05091
45	Neuroscience, Inc	Herndon	Virginia	United States	20170
46	Virginia Commonwealth University	Richmond	Virginia	United States	23219
47	Summit Research Network (Seattle) Llc	Seattle	Washington	United States	98104
48	Dean Foundation For Health Research & Education	Middleton	Wisconsin	United States	53562
49	Local Institution	Caba	Buenos Aires	Argentina	1405
50	Local Institution	Caba	Buenos Aires	Argentina	1425
51	Local Institution	La Plata	Buenos Aires	Argentina	1900
52	Local Institution	Cordoba		Argentina	5000
53	Local Institution	Cordoba		Argentina	5003
54	Local Institution	Mendoza		Argentina	5500
55	Local Institution	Brisbane	Queensland	Australia	4000
56	Local Institution	Adelaide	South Australia	Australia	5112
57	Local Institution	Heidelberg	Victoria	Australia	3084
58	Local Institution	Nedlands	Western Australia	Australia	6009
59	Local Institution	Wien		Austria	1010
60	Local Institution	Wien		Austria	1090
61	Local Institution	Vancouver	British Columbia	Canada	V6Z 2L4
62	Local Institution	Bathurst	New Brunswick	Canada	E2A 4X7
63	Local Institution	Ottawa	Ontario	Canada	K1Z 7K4
64	Local Institution	Toronto	Ontario	Canada	M4W 2N4
65	Local Institution	Montreal	Quebec	Canada	H1N 3V2
66	Local Institution	Montreal	Quebec	Canada	H2R 1V6
67	Local Institution	Dole		France	39100
68	Local Institution	Douai		France	59500
69	Local Institution	Elancourt		France	78990
70	Local Institution	Jonzac Cedex		France	175003
71	Local Institution	Montpellier Cedex 5		France	34295
72	Local Institution	Tirupati	Andhra Pradesh	India	517 507
73	Local Institution	Visakhapatnam	Andhra Pradesh	India	530002
74	Local Institution	Ahmedabad	Gujarat	India	380 006
75	Local Institution	Mumbai	Maharashtra	India	400012
76	Local Institution	Pune	Maharashtra	India	411004
77	Local Institution	Lucknow	Uttar Pradesh	India	226006
78	Local Institution	Chennai		India	600116
79	Local Institution	Pune		India	411030
80	Local Institution	Varanasi		India	211 005
81	Local Institution	Pisa		Italy	56126
82	Local Institution	Roma		Italy	00168
83	Local Institution	Siena		Italy	53100
84	Local Institution	Ponce		Puerto Rico	00731
85	Local Institution	Pretoria	Gauteng	South Africa	0002
86	Local Institution	Pretoria	Gauteng	South Africa	0181
87	Local Institution	Pretoria	Gauteng	South Africa	0187
88	Local Institution	Durban	Kwa Zulu Natal	South Africa	3630
89	Local Institution	Barcelona		Spain	08003
90	Local Institution	Barcelona		Spain	08025
91	Local Institution	London	Greater London	United Kingdom	W6 8RP
92	Local Institution	Edgware	Middlesex	United Kingdom	HA8 0AD
93	Local Institution	Birmingham	West Midlands	United Kingdom	B23 6DW