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Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (STEP-D222)

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ClinicalTrials.gov Identifier: NCT01052077
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: OPC-34712 Drug: Placebo Drug: ADT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Drug: OPC-34712
Tablets, Oral, 1 - 3 mg OPC-34712

Drug: Placebo
Placebo

Drug: ADT
Other Name: FDA Approved Antidepressant (ADT)

Placebo Comparator: Placebo + ADT
Placebo + ADT
Drug: Placebo
Placebo

Drug: ADT
Other Name: FDA Approved Antidepressant (ADT)




Primary Outcome Measures :
  1. Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.


Secondary Outcome Measures :
  1. Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. Scores of 5 and above are associated with significant functional impairment. The SDS total score ranges from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.

  2. Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.

  3. Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.

  4. Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The IDS-SR was a 30-item self-report measure, that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). For individual items, the scores range from 0 to 3. The IDS-SR are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84, higher values indicate greater disruption in the depressive symptoms.

  5. Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the "best" rating and the highest score (2 or 4) was the "worst" rating. The possible total scores were from 0 to 52.

  6. Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participants total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

  7. Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    A MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.

  8. Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit. [ Time Frame: Baseline (end of week 8) to Week 14 ]
    A MADRS remission was defined as MADRS Total Score =< 10 and >= 50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.

  9. Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8). [ Time Frame: Baseline (end of week 8) to Week 14 ]
    CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
  • The current depressive episode must be equal to or greater than 8 weeks in duration
  • Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.

Exclusion Criteria:

  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
  • Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
  • Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
  • Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052077


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Pacific Clinical Research Medical Group
Arcadia, California, United States, 91007
Southwestern Research
Beverly Hills, California, United States, 90210
Excell Research
Oceanside, California, United States, 92056
Affiliated Research Institute
San Diego, California, United States, 92108
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92782
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Florida
CNS Clinical Research Group
Coral Springs, Florida, United States, 33067
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
United States, Georgia
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States, 30328
Carman Research
Smyrna, Georgia, United States, 30080
United States, Indiana
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Maryland
Clinical InSights
Glen Burnie, Maryland, United States, 21061
Pharmasite Research, Inc.
Pikesville, Maryland, United States, 21208
United States, Michigan
MSU/Institute for Health Studies
East Lansing, Michigan, United States, 48824
United States, New Jersey
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11515
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
Medical & Behavioral Health Research, PC
New York, New York, United States, 10023
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Northcoast Clinical Trials
Beachwood, Ohio, United States, 44122
Patient Priority Clinical sites, LLC
Cincinnati, Ohio, United States, 45242
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network (Oregon), LLC
Portland, Oregon, United States, 97210
United States, Pennsylvania
City Line Avenue Family Practice
Bala Cynwyd, Pennsylvania, United States, 19004
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Lincoln Research
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Clinical NeuroScience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Psychiatric Alliance of The Blue Ridge
Charlottesville, Virginia, United States, 22903
NeuroScience, Inc.
Herndon, Virginia, United States, 20170
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104
United States, Wisconsin
Northbrooke Research Center
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01052077     History of Changes
Other Study ID Numbers: 331-09-222
First Posted: January 20, 2010    Key Record Dates
Results First Posted: November 2, 2015
Last Update Posted: November 2, 2015
Last Verified: September 2015
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
Major Depressive Disorder
Adjunctive Treatment
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms