Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia (BEST)
This study has been terminated.
(Study terminated due to failure to meet sufficient enrollment for valid analysis)
Sponsor:
Kettering Health Network
Information provided by (Responsible Party):
Kettering Health Network
ClinicalTrials.gov Identifier:
NCT00712270
First received: July 7, 2008
Last updated: April 20, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Aripiprazole Drug: Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Kettering Health Network:
Primary Outcome Measures:
- Pre and Post Treatment PET and MRI imaging [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assessment of pretreatment and posttreatment psychiatric rating scales to include PANSS and CGI [ Time Frame: 7 visits over 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | April 2005 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard of Care
Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
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Active Comparator: 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.
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Drug: Aripiprazole
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).
Other Name: Abilify
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Active Comparator: Risperidone
Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.
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Drug: Risperidone
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).
Other Name: Risperdal
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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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
- Baseline QTc interval of > 450 msec.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712270
Locations
| United States, Ohio | |
| Wallace Kettering Neuroscience Institute | |
| Kettering, Ohio, United States, 45429 | |
Sponsors and Collaborators
Kettering Health Network
Investigators
| Principal Investigator: | Douglas S Lehrer, MD | Wallace Kettering Neuroscience Institute |
More Information
No publications provided
| Responsible Party: | Kettering Health Network |
| ClinicalTrials.gov Identifier: | NCT00712270 History of Changes |
| Other Study ID Numbers: | 05-009 |
| Study First Received: | July 7, 2008 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kettering Health Network:
|
Schizophrenia Antipsychotic drug treatment response Risperidone Aripiprazole |
Fallypride Positron emission tomography Magnetic Resonance Imaging Dopamine D2 Receptors |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 16, 2013