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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01447576
• Date of registration: 29/09/2011
• Primary sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Public title: Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 1036
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01447576
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Drug: OPC-34712 + ADT

Primary Outcome(s)

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]

Secondary Outcome(s)

The secondary efficacy variables will be as follows: change from baseline in Clinical Global Impression - Severity of Illness scale score. [Time Frame: 56 weeks]

The secondary efficacy variables will be as follows: change from baseline in the mean Clinical Global Impression - Improvement scale score. [Time Frame: 56 weeks]

Secondary ID(s)

331-08-212

Source(s) of Monetary Support

Please refer to primary and secondary sponsors