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

NCT00712270 | Terminated Phase 4 Results

• 1 other identifier: 05-009
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pre and Post Treatment PET and MRI Imaging

  At baseline and 16 weeks

• QTc Measurement

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

Secondary Outcomes (1)

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

  7 visits over 16 weeks

Study Arms (3)

Standard of Care

NO INTERVENTION

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

Drug: Aripiprazole

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

Risperidone

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

Interventions

Aripiprazole DRUG

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).

Also known as: Abilify

Drug: Aripiprazole

Risperidone DRUG

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).

Also known as: Risperdal

Risperidone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kettering Health Network: lead

Study Sites (1)

Wallace Kettering Neuroscience Institute

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines

Limitations and Caveats

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

Results Point of Contact

• Title: Manager, Research Operations and Regulatory Compliance
• Organization: Kettering Health Network

innovationcenter@ketteringhealth.org

937-395-8367

Study Officials

• Douglas S Lehrer, MD

  Wallace Kettering Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2010
• Last Updated: July 28, 2020
• Results First Posted: December 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)