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Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01309945
Collaborator
(none)
889
Enrollment
84
Locations
5
Arms
21.1
Duration (Months)
10.6
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 in the treatment of patients with treatment resistant depression (TRD).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
889 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: Duloxetine 30mg

Drug: Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Names:
  • Cymbalta

    		•
    Placebo Comparator: Arm 2: BMS-820836 placebo

    Drug: Placebo matching with BMS-820836
    Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
    Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day

    Drug: BMS-820836
    Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
    Active Comparator: Arm 4: Duloxetine 30mg

    Drug: Duloxetine
    Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
    Other Names:
  • Cymbalta

    		•
    Placebo Comparator: Arm 5: Duloxetine placebo

    Drug: Placebo matching with Duloxetine
    Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Change in Montgomery Asberg Depression Rating Scale (MADRS) total score [End of phase B and End of phase C]

    Secondary Outcome Measures

    1. Change in Sheehan Disability Scale (SDS) Total score [End of Phase B and End of Phase C]

    2. Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score [End of Phase B and End of Phase C]

    Eligibility Criteria

    Criteria

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

    • 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.

    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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.

    • Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 K & S Professional Research Services, Llc Little Rock Arkansas United States 72201
    2 Pacific Clinical Research Medical Group Arcadia California United States 91007
    3 Pharmacology Research Institute Encino California United States 91316
    4 Collaborative Neuroscience Network, Inc. Garden Grove California United States 92845
    5 Pharmacology Research Institute Los Alamitos California United States 90720
    6 Pharmacology Research Institute Newport Beach California United States 92660
    7 California Neuropsychopharmacology Clinical Research Inst. San Diego California United States 92102
    8 Pacific Research Network, Inc San Diego California United States 92103
    9 California Neuroscience Research Medical Group, Inc. Sherman Oaks California United States 91403
    10 Schuster Medical Research Institute Sherman Oaks California United States 91403
    11 Pacific Clinical Research Medical Group Upland California United States 91786
    12 Radiant Research, Inc. Denver Colorado United States 80239
    13 Comprehensive Psychiatric Care Norwich Connecticut United States 06360
    14 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
    15 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32806
    16 Compass Research, Llc Orlando Florida United States 32806
    17 Comprehensive Clinical Development, Inc. St Petersburg Florida United States 33716
    18 Atlanta Institute Of Medicine & Research Atlanta Georgia United States 30328
    19 Comprehensive Clinical Development, Inc. Atlanta Georgia United States 30328
    20 Carman Research Smyrna Georgia United States 30080
    21 Loyola University Health System Maywood Illinois United States 60153
    22 Alpine Clinic Lafayette Indiana United States 47905
    23 Clinical Trials Technology, Inc Prairie Village Kansas United States 66206
    24 James G. Barbee, Md, Llc New Orleans Louisiana United States 70115
    25 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    26 Neurobehavioral Research, Inc. Cedarhurst New York United States 11516
    27 Finger Lakes Clinical Research Rochester New York United States 14618
    28 Richard H. Weisler, Md, Pa & Assoc. Raleigh North Carolina United States 27609
    29 Midwest Clinical Research Center Dayton Ohio United States 45417
    30 Ips Research Company Oklahoma City Oklahoma United States 73103
    31 Tulsa Clinical Research, Llc Tulsa Oklahoma United States 74104
    32 Oregon Center For Clinical Investigations, Inc. (Occi, Inc) Portland Oregon United States 97210
    33 Summit Research Network (Oregon) Inc Portland Oregon United States 97210
    34 Oregon Center For Clinical Investigations, Inc (Occi, Inc) Salem Oregon United States 97301
    35 Lehigh Center For Clinical Research Allentown Pennsylvania United States 18104
    36 Univ Of Penn Philadelphia Pennsylvania United States 19104
    37 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    38 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    39 Belmont Center For Comprehensive Treatment Philadelphia Pennsylvania United States 19131
    40 University Of Pennsylvania Philadephia Pennsylvania United States 19104
    41 Carolina Clinical Research Services Columbia South Carolina United States 29201
    42 University Of South Carolina School Of Medicine Columbia South Carolina United States 29203
    43 Psychiatric Consultants, Pc Franklin Tennessee United States 37067
    44 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
    45 Community Clinical Research, Inc. Austin Texas United States 78754
    46 Uthealth - Houston Houston Texas United States 77054
    47 Red Oak Psychiatry Associates Houston Texas United States 77090
    48 San Antonio Psychiatric Research Center San Antonio Texas United States 78229
    49 Radiant Research, Inc. Murray Utah United States 84123
    50 Psychiatric And Behavioral Solutions Salt Lake City Utah United States 84105
    51 Northwest Clinical Research Center Bellevue Washington United States 98004
    52 Summit Research Network (Seattle) Llc Seattle Washington United States 98104
    53 Northbrooke Research Center Brown Deer Wisconsin United States 53223
    54 Dean Foundation For Health Research & Education Middleton Wisconsin United States 53562
    55 Independent Psychiatric Consultants, Sc, Dba, Ipc Research Waukesha Wisconsin United States 53188
    56 Local Institution Edmonton Alberta Canada T6L 6W6
    57 Local Institution Vancouver British Columbia Canada V6T 2A1
    58 Local Institution Toronto Ontario Canada M5g 2n2
    59 Local Institution Montreal Quebec Canada H4H 1R3
    60 Local Institution Quebec Canada G3K 2P8
    61 Local Institution Helsinki Finland 00100
    62 Local Institution Helsinki Finland 00260
    63 Local Institution Jarvenpaa Finland 04400
    64 Local Institution Oulu Finland 90100
    65 Local Institution Seinajoki Finland 60100
    66 Local Institution Tampere Finland 33200
    67 Local Institution Turku Finland 20100
    68 Local Institution Dole France 39100
    69 Local Institution Douai France 59500
    70 Local Institution Elancourt France 78990
    71 Local Institution Limoges Cedex France 87025
    72 Local Institution Montpellier Cedex 5 France 34295
    73 Local Institution Nimes France 30900
    74 Local Institution Paris France 75012
    75 Local Institution Johannesburg Gauteng South Africa 2195
    76 Local Institution Pretoria Gauteng South Africa 0183
    77 Local Institution Vereeniging Gauteng South Africa 1939
    78 Local Institution Bellville Western Cape South Africa 7535
    79 Local Institution Cape Town Western Cape South Africa 7530
    80 Local Institution Somerset West Western Cape South Africa 7130
    81 Local Institution Halmstad Sweden 302 48
    82 Local Institution Kungens Kurva Sweden 141 75
    83 Local Institution Lund Sweden 222 22
    84 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:
    NCT01309945
    Other Study ID Numbers:
    • CN162-006
    • 2010-022841-93
    First Posted:
    Mar 7, 2011
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Duloxetine Hydrochloride

    Study Results

    No Results Posted as of Oct 12, 2015