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Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia (BEST)

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

Risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic drug treatment response, Risperidone, Aripiprazole, Fallypride, Positron emission tomography, Magnetic Resonance Imaging, Dopamine D2 Receptors

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wallace Kettering Neuroscience Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Drug: Aripiprazole

Risperidone

Arm Description

Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.

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

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

Outcomes

Primary Outcome Measures

Pre and Post Treatment PET and MRI Imaging

QTc Measurement

Information regarding the Outcome Measure being a Primary or Secondary, is unavailable.

Secondary Outcome Measures

Assessment of Pretreatment and Posttreatment Psychiatric Rating Scales to Include PANSS and CGI

Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.

Full Information

NCT ID

NCT00712270

First Posted

July 7, 2008

Last Updated

July 10, 2020

Sponsor

Kettering Health Network

1. Study Identification

Unique Protocol Identification Number

NCT00712270

Brief Title

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

Acronym

BEST

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Terminated

Why Stopped

Study terminated due to failure to meet sufficient enrollment for valid analysis

Study Start Date

April 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kettering Health Network

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Antipsychotic drug treatment response, Risperidone, Aripiprazole, Fallypride, Positron emission tomography, Magnetic Resonance Imaging, Dopamine D2 Receptors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.

Arm Title

Drug: Aripiprazole

Arm Type

Active Comparator

Arm Description

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

Arm Title

Risperidone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

Risperdal

Intervention Description

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).

Primary Outcome Measure Information:

Title

Pre and Post Treatment PET and MRI Imaging

Time Frame

At baseline and 16 weeks

Title

QTc Measurement

Description

Information regarding the Outcome Measure being a Primary or Secondary, is unavailable.

Secondary Outcome Measure Information:

Title

Assessment of Pretreatment and Posttreatment Psychiatric Rating Scales to Include PANSS and CGI

Description

Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.

Time Frame

7 visits over 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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; Baseline QTc interval of > 450 msec.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas S Lehrer, MD

Organizational Affiliation

Wallace Kettering Neuroscience Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wallace Kettering Neuroscience Institute

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

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