Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01447576
First received: September 29, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).


Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Fluoxetine
Drug: Paroxetine CR
Drug: Sertraline
Drug: Citalopram Hydrobromide
Drug: Desvenlafaxine
Drug: Venlafaxine XR
Drug: Duloxetine Hydrochloride
Drug: Bupropion
Drug: OPC-34712
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • The primary outcome variable is the safety and tolerability of OPC-34712 which will be assessed by examining the frequency and severity of adverse events (AEs). [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary efficacy variables will be as follows: change from baseline in Clinical Global Impression - Severity of Illness scale score. [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
  • The secondary efficacy variables will be as follows: change from baseline in the mean Clinical Global Impression - Improvement scale score. [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1036
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Escitalopram Tablets, Oral, 10 - 20 mg
Drug: Escitalopram
Once daily dosing during the duration of the study.
Other Name: Lexapro
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Fluoxetine and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Fluoxetine, oral capsules, 20 - 40 mg
Drug: Fluoxetine
Fluoxetine 40 mg can be administered once daily or in divided doses twice daily
Other Name: Prozac
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Paroxetine CR and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Paroxetine CR Tablets, Oral, 37.5 - 50 mg
Drug: Paroxetine CR
Once daily dosing during the duration of the study.
Other Name: Paxil CR
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Sertraline and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Sertraline Tablets, Oral, 100 - 150 mg
Drug: Sertraline
Once daily dosing during the duration of the study.
Other Name: Zoloft
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Citalopram Hydrobromide and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Citalopram Hydrobromide Tablets, Oral, 20 - 40 mg
Drug: Citalopram Hydrobromide
Once daily dosing during the duration of the study.
Other Name: Celexa
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Desvenlafaxine and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Desvenlafaxine Extended ReleaseTablets, Oral, 50 - 100 mg
Drug: Desvenlafaxine
Once daily dosing during the duration of the study.
Other Name: Pristiq
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Venlafaxine XR and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Venlafaxine Extended Release capsules, Oral, 75 - 225 mg
Drug: Venlafaxine XR
Once daily dosing during the duration of the study.
Other Name: Effexor XR
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Duloxetine Hydrochloride and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Duloxetine Hydrochloride Capsules, Oral, 40 - 60 mg
Drug: Duloxetine Hydrochloride
Once daily dosing during the duration of the study.
Other Name: Cymbalta
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
Experimental: Bupropion and OPC-34712
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Drug: Bupropion Tablets, Oral, 300 - 450 mg
Drug: Bupropion
Once daily dosing during the duration of the study.
Other Name: Wellbutrin XL
Drug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
  • Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
  • Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four 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, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
  • Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447576

  Show 32 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01447576     History of Changes
Other Study ID Numbers: 331-08-212
Study First Received: September 29, 2011
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Bupropion
Citalopram
Dexetimide
Duloxetine
Fluoxetine
O-desmethylvenlafaxine
Paroxetine
Sertraline
Venlafaxine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014