Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole; Risperidone
Intervention description: Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).; Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
Intervention MeSH terms: Risperidone; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Antipsychotic drug treatment response; Risperidone; Aripiprazole; Fallypride; Positron emission tomography; Magnetic Resonance Imaging; Dopamine D2 Receptors

Summary:

      This study is being conducted to find a way to predict how individual schizophrenic patients
      will respond if they are treated with different types of antipsychotic drugs. This could help
      doctors prescribe the medication that will work best for each individual.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects will meet DSM-IV diagnostic criteria for schizophreniform disorder,
             schizophrenia, schizoaffective disorder or (non-affective) psychotic disorder, NOS.
             Subjects with schizophreniform disorder or psychotic disorder, NOS, will be
             diagnostically reevaluated (recontacted if no longer involved in the study) after a
             minimum of six months of psychotic symptoms in order to determine whether diagnostic
             criteria for schizophrenia or schizoaffective disorder have been met.

          2. Subjects will be between 18 and 55 years of age, inclusive.

          3. Subjects will be able to fully participate in the informed consent process, or have a
             legal guardian able to participate in the informed consent process.

          4. Present score on at least one PANSS psychosis items (P1, P2, P3, P5 or P6) >
             4(moderately severe) and CGI Severity score > 4 (moderate).

          5. Female patients of childbearing potential must be using a medically accepted means of
             contraception

        Exclusion Criteria:

          1. Current active substance use disorder diagnosis or a history of cocaine abuse or
             dependence;

          2. Female patients who are either pregnant or nursing;

          3. Known history of mental retardation, seizure disorder, or a clinically significant
             head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated
             structural brain injury);

          4. Non-English speaking (mastery of English insufficient to participate in study
             evaluation procedures);

          5. Serious, unstable medical illness;

          6. Known hypersensitivity to any study medication;

          7. Medical contraindication to any element of the study procedure;

          8. Current symptoms which present serious risk of danger to self or others;

          9. Participation in a clinical trial of an investigational drug within 30 days of study
             entry;

         10. Current severity of psychiatric symptoms contraindicates a delay in initiation of
             antipsychotic medication treatment until functional imaging studies and
             neuropsychological testing have been completed;

         11. Baseline QTc interval of > 450 msec.