Overview

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

Status:
Terminated

Trial end date:
2010-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kettering Health Network

Treatments:

Aripiprazole
Risperidone

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.