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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: OPC-34712; Drug: ADT; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797966

331-08-211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 850 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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850 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

OPC-34712 + ADT

Treatment:

Drug: ADT

Drug: OPC-34712

2

Placebo Comparator group

Description:

Placebo + ADT

Treatment:

Drug: Placebo

Drug: ADT