Clinical trial NCT00712270: Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia
Official title: A Randomized Double-blind Trial of Aripiprazole and Risperidone in Schizophrenia: An Evaluation of Neuroimaging, Neuropsychological, and Pharmacogenomic Markers of Differential Treatment Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic drug treatment response
Risperidone
Aripiprazole
Fallypride
Positron emission tomography
Magnetic Resonance Imaging
Dopamine D2 Receptors
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pre and Post Treatment PET and MRI Imaging
timeFrame: At baseline and 16 weeks
measure: QTc Measurement
Secondary outcomes:
measure: Assessment of Pretreatment and Posttreatment Psychiatric Rating Scales to Include PANSS and CGI
timeFrame: 7 visits over 16 weeks
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Wallace Kettering Neuroscience Institute
state: Ohio
Study officials:
affiliation: Wallace Kettering Neuroscience Institute
name: Douglas S Lehrer, MD
role: PRINCIPAL_INVESTIGATOR
References: