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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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Otsuka

Status and phase

Completed
Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo
Drug: OPC-34712
Drug: ADT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01052077
331-09-222

Details and patient eligibility

About

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.

Enrollment

773 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

773 participants in 2 patient groups, including a placebo group

Brexipiprazole + ADT
Experimental group
Description:
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Treatment:
Drug: ADT
Drug: Placebo
Drug: OPC-34712
Placebo + ADT
Placebo Comparator group
Description:
Placebo + ADT
Treatment:
Drug: ADT
Drug: Placebo

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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