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Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia (BEST)
This study is currently recruiting participants.
Verified by Kettering Health Network, July 2008
Sponsored by: Kettering Health Network
Information provided by: Kettering Health Network
ClinicalTrials.gov Identifier: NCT00712270
  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 IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone Dopamine Dopamine hydrochloride Aripiprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment: 125
Study Start Date: April 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
2: Active Comparator
Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.
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).
3: Active Comparator
Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.
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).

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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712270

Contacts
Contact: Douglas S Lehrer, MD 937-395-8251 doug.lehrer@khnetwork.org
Contact: Michele Jewell, MA 937-298-3399 ext 55415 michele.jewell@khnetwork.org

Locations
United States, Ohio
Wallace Kettering Neuroscience Institute Recruiting
Kettering, Ohio, United States, 45429
Contact: Douglas S Lehrer, MD     937-395-8251     doug.lehrer@khnetwork.org    
Contact: Michele Jewell, MA     937-298-3399 ext 55415     michele.jewell@khnetwork.org    
Principal Investigator: Douglas S. Lehrer, MD            
Sponsors and Collaborators
Kettering Health Network
Investigators
Principal Investigator: Douglas S Lehrer, MD Wallace Kettering Neuroscience Institute
  More Information

Responsible Party: Wallace Kettering Neuroscience Institute ( Douglas S. Lehrer, MD )
Study ID Numbers: 05-009
Study First Received: July 7, 2008
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00712270  
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

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Aripiprazole
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009