A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients with Acute Schizophrenia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

1. Subjects who are able to provide written informed consent (as required by IRB/IEC), prior to the initiation of any protocol-required procedures.
2. Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
3. Subjects with a stable living environment when not in hospital, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
4. Male and female subjects 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria and confirmed by the M.I.N.I. for Psychotic Disorders
5. Subjects who have been recently hospitalized (ie, < 14 days prior to Screening) or who would benefit from hospitalization for treatment of a current acute relapse of schizophrenia at study entry.
6. Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by a PANSS Total Score = 80 AND CGI-S score =4 (moderately ill) at the Screening and Baseline visit.
7. Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration and who showed a previous response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigator’s opinion.
8. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
9. Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Sexually active males or females of child-bearing potential who are not practicing two different, acceptable (as defined by the protocol) methods of birth control during the study and for the prescribed periods after last dose of study drug.
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
3. Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.
6. Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia (see protocol for details).
8. Subjects with a significant risk of violent behaviour; who represent a risk of committing suicide as indicated by any suicidal ideation within the last 6 months or any suicidal behaviours within the last two years; or who in the clinical judgment of the investigator present a serious risk of suicide.
18. Patients having laboratory test and ECG results outwith limits prescribed in the protocol.
25. Subjects who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.
26. Any subject who, in the opinion of the investigator, should not participate in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the optimal dose of OPC-34712 for the treatment of acute schizophrenia based on efficacy, safety, and tolerability during a 6-week treatment period.;Secondary Objective: ;Primary end point(s): The primary outcome variable for determination of efficacy is the change from baseline to Week 6/Early Termination (ET) in PANSS Total Score using the last-observation-carried-forward (LOCF) dataset.

Secondary Outcome Measures

Name	Time	Method

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