Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00797966
- Brief Summary
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
- Detailed Description
A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 OPC-34712 OPC-34712 + ADT 2 Placebo Placebo + ADT 2 ADT Placebo + ADT 1 ADT OPC-34712 + ADT
- Primary Outcome Measures
Name Time Method Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. Week 8 to Week 14 The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists 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. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are 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 to the first decimal place.
- Secondary Outcome Measures
Name Time Method Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score. Week 8 to Week 14 CGI-S items are: 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, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items). Week 8 to Week 14 The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5\*(minimum score). Range is maximum score minus minimum score. Total score is 100\*(Raw score minus minimum score)/ Range, rounded to nearest integer.
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores). Week 8 to Week 14 The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. 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 will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit. Week 8 to each of Week 9, 10, 11, 12 and 13. The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists 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. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are 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 to the first decimal place.
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit. Week 8 to each of Week 9, 10, 11, 12 and 13. CGI-S items are: 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, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication). Week 8 to Week 14 The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction). Week 8 to Week 14 The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.
Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score. Week 8 to each of Week 9, 10, 11, 12, 13 and 14 The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score. Week 8 to Week 14 The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are 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) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the "best" rating and the highest score (2 or 4) is the "worst" rating. The possible total scores are from 0 to 52.
Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B. Week 8 to each of Week 9, 10, 11, 12, 13 and 14. CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.
Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit). Week 8 to each of Week 9, 10, 11, 12, 13 and 14. A MADRS response was defined as \>/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).
Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit). Week 8 to each of Week 9, 10, 11, 12, 13 and 14. A MADRS remission was defined as MADRS Total Score \</= 10 and \>/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).
Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit). Week 9, 10, 11, 12, 13 and 14. CGI-I response is defined as CGI-I of 1 \[very much improved\] or 2 \[much improved\].
Trial Locations
- Locations (50)
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Vince & Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
CNS Clinical Research Group
🇺🇸Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Synergy Escondido
🇺🇸Escondido, California, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
NorthCoast Clinical Trials, Inc
🇺🇸Beachwood, Ohio, United States
FutureSearch Clinical Trials
🇺🇸Austin, Texas, United States
Pacific Clinical Research Medical Group
🇺🇸Arcadia, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Patient Priority Clinical Sites, LLC
🇺🇸Cinncinnati, Ohio, United States
Clinical Neurosciences Solutions
🇺🇸Orlando, Florida, United States
Janus Center
🇺🇸West Palm Beach, Florida, United States
NorthStar Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
NeuroScience, Inc.
🇺🇸Herndon, Virginia, United States
Northbrooke Research Center
🇺🇸Brown Deer, Wisconsin, United States
Carolinas HealthCare - Behavioral Heath Center
🇺🇸Charlotte, North Carolina, United States
Psychiatric Alliance of the Blue Ridge
🇺🇸Charlottesville, Virginia, United States
Midwest Center for Neurobehavioral Medicine
🇺🇸Oakbrook Terrace, Illinois, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
USC School of Medicine- Department of Neuropsychiatry and Behavioral Science
🇺🇸Columbia, South Carolina, United States
Eastside Comprehensive Medical Center
🇺🇸New York City, New York, United States
Dean Foundation
🇺🇸Middleton, Wisconsin, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Mood Disorders Clinic
🇺🇸Salt Lake City, Utah, United States
The Davis Clinic, PC
🇺🇸Indianapolis, Indiana, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Radiant Research Center
🇺🇸Denver, Colorado, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
University of South Florida College of Medicine Psychiatry Center
🇺🇸Tampa, Florida, United States
Summitt Research Network (Oregon)
🇺🇸Portland, Oregon, United States
Excell Research
🇺🇸Oceanside, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Accurate Clinical Trials
🇺🇸Kissimee, Florida, United States
Bioscience Research
🇺🇸Mount Kisco, New York, United States
Medical & Behavioral Health Research, PC
🇺🇸New York, New York, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Clinical Neurosciences Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Southwestern Research
🇺🇸Beverly Hills, California, United States
Collaborative Neuroscience Network Inc.
🇺🇸Garden Grove, California, United States
Radiant Research
🇺🇸Salt Lake City, Utah, United States