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Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT01361555
Collaborator
(none)
789
Enrollment
144
Locations
3
Arms
26
Duration (Months)
5.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
789 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Placebo + BMS-820836 (0.5 mg/day)

Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks

Drug: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
Experimental: Arm 2: Placebo + BMS-820836 (1 mg/day)

Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks

Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Experimental: Arm 3: Placebo + BMS-820836 (2 mg/day)

Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks

Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks

Outcome Measures

Primary Outcome Measures

  1. Long-term effects of BMS-820836 on blood pressure in patients with depression [Baseline through Week 54]

Secondary Outcome Measures

  1. • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs [Baseline through Week 54]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Psychiatry Pharmaceutical Studies, Inc. Birmingham Alabama United States 35226
2 K & S Professional Research Services, Llc Little Rock Arkansas United States 72201
3 Arkansas Psychiatric Clinic Clinical Research Trials, P.A. Little Rock Arkansas United States 72223
4 Pacific Clinical Research Medical Group Arcadia California United States 91007
5 Catalina Research Institute, Llc Chino California United States 91710
6 Pharmacology Research Institute Encino California United States 91316
7 Collaborative Neuroscience Network, Inc. Garden Grove California United States 92845
8 Behavioral Research Specialists, Llc Glendale California United States 91206
9 Pharmacology Research Institute Los Alamitos California United States 90720
10 Pharmacology Research Institute Newport Beach California United States 92660
11 Neuropsychiatric Research Center Of Orange County Orange California United States 92868
12 Pacific Clinical Research Medical Group Orange California United States 92868
13 Anderson Clinical Research Redlands California United States 92374
14 California Neuropsychopharmacology Clinical San Diego California United States 92102
15 Pacific Research Network San Diego California United States 92103
16 Affiliated Research Institute San Diego California United States 92108
17 Artemis Institute For Clinical Research San Diego California United States 92123
18 Sharp Mesa Vista Hospital San Diego California United States 92123
19 California Neuroscience Research Medical Group, Inc. Sherman Oaks California United States 91403
20 Schuster Medical Research Institute Sherman Oaks California United States 91403
21 Pacific Clinical Research Medical Group Upland California United States 91786
22 Western Affiliated Research Institute Denver Colorado United States 80209
23 Radiant Research, Inc. Denver Colorado United States 80239
24 Connecticut Clinical Research Cromwell Connecticut United States 06416
25 Meridien Research Brooksville Florida United States 34601
26 Gulfcoast Clinical Research Center Fort Myers Florida United States 33912
27 Amit Vijapura Jacksonville Florida United States 32256
28 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
29 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32806
30 Compass Research, Llc Orlando Florida United States 32806
31 Comprehensive Clinical Development, Inc. Saint Petersburg Florida United States 33716
32 Stedman Clinical Trials Tampa Florida United States 33613
33 Janus Center For Psychiatric Research West Palm Beach Florida United States 33407
34 Emory University Atlanta Georgia United States 30306
35 Atlanta Institute Of Medicine & Research Atlanta Georgia United States 30328
36 Comprehensive Clinical Development, Inc Atlanta Georgia United States 30328
37 Carman Research Smyrna Georgia United States 30080
38 Loyola University Medical Center Maywood Illinois United States 60153
39 Alpine Clinic Lafayette Indiana United States 47905
40 Clinco Terre Haute Indiana United States 47802
41 Clinical Trials Technology, Inc Prairie Village Kansas United States 66206
42 James G. Barbee, Md, Llc New Orleans Louisiana United States 70115
43 J. Gary Booker, Md, Apmc Shreveport Louisiana United States 71104
44 Mclean Hospital Belmont Massachusetts United States 02478
45 Bio Behavioral Health Toms River New Jersey United States 08755
46 Albuquerque Neuroscience, Inc. Albuquerque New Mexico United States 87109
47 Spri Clinical Trials, Llc Brooklyn New York United States 11235
48 Neurobehavioral Research, Inc. Cedarhurst New York United States 11516
49 Comprehensive Clinical Development, Inc Jamaica New York United States 11432
50 Village Clinical Research, Inc. New York New York United States 10003
51 Finger Lakes Clinical Research Rochester New York United States 14618
52 Carolinas Healthcare System Charlotte North Carolina United States 28203
53 Richard H. Weisler, Md, Pa & Assoc. Raleigh North Carolina United States 27609
54 Northcoast Clinical Trials, Inc Beachwood Ohio United States 44122
55 Patient Priority Clinical Sites, Llc Cincinnati Ohio United States 45215
56 Midwest Clinical Research Center Dayton Ohio United States 45417
57 Neurology & Neuroscience Center Of Ohio Toledo Ohio United States 43623
58 Ips Research Company Oklahoma City Oklahoma United States 73103
59 Tulsa Clinical Research, Llc Tulsa Oklahoma United States 74104
60 Oregon Center For Clinical Investigations, Inc. (Occi, Inc) Portland Oregon United States 97210
61 Summit Research Network (Oregon) Inc Portland Oregon United States 97210
62 Oregon Center For Clinical Investigations, Inc (Occi, Inc) Salem Oregon United States 97301
63 Lehigh Center For Clinical Research Allentown Pennsylvania United States 18104
64 Suburban Research Associates Media Pennsylvania United States 19063
65 Keystone Clinical Studies, Llc Norristown Pennsylvania United States 19403
66 Univ Of Penn Philadelphia Pennsylvania United States 19104-3309
67 University Of Pennsylvania Philadelphia Pennsylvania United States 19104-3309
68 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
69 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
70 Comprehensive Psychiatric Care Pittsburgh Pennsylvania United States 06360
71 Bioscience Research, Llc Pittsburgh Pennsylvania United States 15219
72 Insite Clinical Research Pittsburgh Pennsylvania United States 15219
73 Lincoln Research Lincoln Rhode Island United States 02865
74 Carolina Clinical Research Services Columbia South Carolina United States 29201
75 Psychiatric Consultants, Pc Franklin Tennessee United States 37067
76 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
77 Futuresearch Trials Austin Texas United States 78731
78 Community Clinical Research, Inc. Austin Texas United States 78754
79 Futuresearch Trials Of Dallas Dallas Texas United States 75231
80 Baylor College Of Medicine Houston Texas United States 77030
81 Ut Health-Houston Houston Texas United States 77054
82 Red Oak Psychiatry Associates, Pa Houston Texas United States 77090
83 San Antonio Psychiatric Research Center San Antonio Texas United States 78229
84 Grayline Clinical Drug Trials Wichita Falls Texas United States 76309
85 Ericksen Research And Development Clinton Utah United States 84015
86 Radiant Research, Inc. Murray Utah United States 84123
87 Psychiatric And Behavioral Solutions Salt Lake City Utah United States 84105
88 Lifetree Clinical Research Salt Lake City Utah United States 84106
89 Neuropsychiatric Associates Woodstock Vermont United States 05091
90 Northwest Clinical Research Center Bellevue Washington United States 98007
91 Summit Research Network (Seattle) Llc Seattle Washington United States 98104
92 Northbrooke Research Center Brown Deer Wisconsin United States 53223
93 Dean Foundation For Health Research & Education Middleton Wisconsin United States 53562
94 Independent Psychiatric Consultants, Sc, Dba, Ipc Research Waukesha Wisconsin United States 53188
95 Local Institution Caba Buenos Aires Argentina 1405
96 Local Institution Caba Buenos Aires Argentina 1425
97 Local Institution La Plata Buenos Aires Argentina 1900
98 Local Institution Cordoba Argentina 5000
99 Local Institution Cordoba Argentina 5003
100 Local Institution Mendoza Argentina 5500
101 Local Institution Brisbane Queensland Australia 4000
102 Local Institution Adelaide South Australia Australia 5112
103 Local Institution Heidelberg Victoria Australia 3084
104 Local Institution Nedlands Western Australia Australia 6009
105 Local Institution Wien Austria 1010
106 Local Institution Wien Austria 1090
107 Local Institution Helsinki Finland 00100
108 Local Institution Helsinki Finland 00260
109 Local Institution Jarvenpaa Finland 04400
110 Local Institution Oulu Finland 90100
111 Local Institution Seinajoki Finland 60100
112 Local Institution Tampere Finland 33200
113 Local Institution Turku Finland 20100
114 Local Institution Dole France 39108
115 Local Institution Douai France 59500
116 Local Institution Elancourt France 78990
117 Local Institution Jonzac France 17503
118 Local Institution Limoges Cedex France 87025
119 Local Institution Montpellier Cedex 5 France 34295
120 Local Institution Paris France 75012
121 Local Institution Ahmedabad Gujarat India 380 006
122 Local Institution Mumbai Maharashtra India 400012
123 Local Institution Pune Maharashtra India 411004
124 Local Institution Chennai India 600116
125 Local Institution Pune India 411030
126 Local Institution Varanasi India 211 005
127 Local Institution Vishakapattanam India 530002
128 Local Institution Pisa Italy 56100
129 Local Institution Siena Italy 53100
130 Local Institution Ponce Puerto Rico 00730
131 Local Institution Johannesburg Gauteng South Africa 2195
132 Local Institution Pretoria Gauteng South Africa 0002
133 Local Institution Pretoria Gauteng South Africa 0181
134 Local Institution Pretoria Gauteng South Africa 0187
135 Local Institution Durban Kwa Zulu Natal South Africa 3630
136 Local Institution Cape Town Western Cape South Africa 7530
137 Local Institution Arganda Del Rey Spain 28500
138 Local Institution Barcelona Spain 08003
139 Local Institution Barcelona Spain 08025
140 Local Institution Madrid Spain 28006
141 Local Institution Halmstad Sweden 302 48
142 Local Institution Kungens Kurva Sweden 14175
143 Local Institution Lund Sweden 22222
144 Local Institution Uppsala Sweden 751 85

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01361555
Other Study ID Numbers:
  • CN162-010
  • 2010-024371-12
First Posted:
May 27, 2011
Last Update Posted:
Oct 12, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Depression
Depressive Disorder

Study Results

No Results Posted as of Oct 12, 2015