schizophrenia MedDRA version: 12.0 Level: LLT Classification code 10001064 Term: Acute schizophrenia
Conditions
Interventions
Product Code: OPC-34712
Pharmaceutical Form: Tablet
Current Sponsor code: OPC-34712
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 behaviour 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Bulgaria, Slovakia
Outcome results
None listed