A Randomized Double-blind Trial of Aripiprazole and Risperidone in Schizophrenia: An Evaluation of Neuroimaging, Neuropsychological, and Pharmacogenomic Markers of Differential Treatment Response

Kettering Health Network1 site in 1 country21 target enrollmentApril 2005

ConditionsSchizophrenia

InterventionsAripiprazole Risperidone

DrugsAripiprazole Risperidone

Overview

Phase: Phase 4
Intervention: Aripiprazole
Conditions: Schizophrenia
Sponsor: Kettering Health Network
Enrollment: 21
Locations: 1
Primary Endpoint: QTc Measurement
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The primary objective of the proposed research project is to identify a practical method of predicting differential antipsychotic drug treatment response in patients with schizophrenia. In particular, we will examine differential response to two antipsychotic drugs, aripiprazole and risperidone, that have contrasting pharmacologic activity at D2-type dopamine receptors, i.e., partial agonism vs. antagonism, respectively. A number of candidate predictors will be examined, including neuroimaging parameters (regional neuroanatomical and metabolic variations, fallypride binding to D2-like receptors), neuropsychological testing, clinical features, laboratory measures, and genetic studies. Secondary objectives include: (1) extension of our previous efforts to characterize abnormalities in cortico-striato-thalamic circuits in unmedicated schizophrenics using PET and MR imaging; and, (2) examination of the role of omega-3 fatty acid activity in schizophrenics as a predictor of dopaminergic activity.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

November 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kettering Health Network

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Subjects will be between 18 and 55 years of age, inclusive.
•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.
•Present score on at least one PANSS psychosis items (P1, P2, P3, P5 or P6) \> 4(moderately severe) and CGI Severity score \> 4 (moderate).
•Female patients of childbearing potential must be using a medically accepted means of contraception

Exclusion Criteria

•Current active substance use disorder diagnosis or a history of cocaine abuse or dependence;
•Female patients who are either pregnant or nursing;
•Known history of mental retardation, seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
•Non-English speaking (mastery of English insufficient to participate in study evaluation procedures);
•Serious, unstable medical illness;
•Known hypersensitivity to any study medication;
•Medical contraindication to any element of the study procedure;
•Current symptoms which present serious risk of danger to self or others;
•Participation in a clinical trial of an investigational drug within 30 days of study entry;
•Current severity of psychiatric symptoms contraindicates a delay in initiation of antipsychotic medication treatment until functional imaging studies and neuropsychological testing have been completed;

Arms & Interventions

Drug: Aripiprazole

Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.

Intervention: Aripiprazole

Risperidone

Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.

Intervention: Risperidone