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

Major Depressive Disorder Clinical Trial

— STEP-D222  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052077
• Other study ID #: 331-09-222
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: September 30, 2015
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: September 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 773
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• OPC-34712
Tablets, Oral, 1 - 3 mg OPC-34712
• Placebo
Placebo
• ADT

Locations

Country	Name	City	State
United States	Pacific Clinical Research Medical Group	Arcadia	California
United States	Comprehensive NeuroScience, Inc.	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	City Line Avenue Family Practice	Bala Cynwyd	Pennsylvania
United States	Northcoast Clinical Trials	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Southwestern Research	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Psychiatric Alliance of The Blue Ridge	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Patient Priority Clinical sites, LLC	Cincinnati	Ohio
United States	CNS Clinical Research Group	Coral Springs	Florida
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	MSU/Institute for Health Studies	East Lansing	Michigan
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Clinical InSights	Glen Burnie	Maryland
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Lincoln Research	Lincoln	Rhode Island
United States	Clinical NeuroScience Solutions, Inc.	Memphis	Tennessee
United States	Eastside Comprehensive Medical Center	New York	New York
United States	Medical & Behavioral Health Research, PC	New York	New York
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Excell Research	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pharmasite Research, Inc.	Pikesville	Maryland
United States	Summit Research Network (Oregon), LLC	Portland	Oregon
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Radiant Research	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Affiliated Research Institute	San Diego	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Summit Research Network (Seattle), LLC	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Carman Research	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.	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.	Baseline (end of week 8) to Week 14	No
Secondary	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.	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.	Baseline (end of week 8) to Week 14	No
Secondary	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.	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.	Baseline (end of week 8) to Week 14	No
Secondary	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.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.	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.	Baseline (end of week 8) to Week 14	No
Secondary	Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).	CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).	Baseline (end of week 8) to Week 14	No