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:
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
  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.
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.
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
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.
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014