Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia (VECTOR)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Acute Schizophrenia

Treatments: Drug: Experimental: OPC-34712 [Brexpiprazole] Low Dose; Drug: Experimental: OPC-34712 [Brexpiprazole] Middle Dose; Drug: Placebo; Drug: OPC-34712 [Brexpiprazole] High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396421

331-10-231

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Full description

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Enrollment: 636 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms
4. Other protocol specific inclusion criteria may apply

Exclusion criteria

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   • Schizoaffective disorder
   • Major depressive disorder (MDD)
   • Bipolar disorder
   • Delirium, dementia, amnestic or other cognitive disorder
   • Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder

3. Subjects presenting with a first episode of schizophrenia

4. Other protocol specific exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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636 participants in 4 patient groups, including a placebo group

OPC-34712 [Brexpiprazole] High Dose

Experimental group

Description:

Higher Dose, tablet, once daily, for six weeks

Treatment:

Drug: OPC-34712 [Brexpiprazole] High Dose

OPC-34712 [Brexpiprazole] Middle Dose

Experimental group

Description:

Middle Dose, tablet, once daily, for six weeks

Treatment:

Drug: Experimental: OPC-34712 [Brexpiprazole] Middle Dose

OPC-34712 [Brexpiprazole] Low Dose

Experimental group

Description:

Lower Dose, tablet, once daily, for six weeks

Treatment:

Drug: Experimental: OPC-34712 [Brexpiprazole] Low Dose

Placebo

Placebo Comparator group

Description:

Placebo, once daily, for six weeks

Treatment:

Drug: Placebo