Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-01-31

Brief Summary

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This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.

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A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder

NCT00297388

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE3

Detailed Description

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As is the case with many chronic illnesses, it can be challenging for people with schizophrenia to take multiple pills every day on a long-term basis. At the same time, missing or discontinuing the anti-psychotic medications that treat schizophrenia substantially increases the risk of relapse and re-hospitalization. This study will determine how effective long-acting injectable risperidone is compared to oral antipsychotic medications to help patients who have schizophrenia. Patients who enroll in the study will be randomly assigned to receive either long-acting injectable risperidone or to receive oral "atypical" antipsychotic medication. The "atypical" antipsychotics that are included for patients in the oral group are: aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. Patients in the "oral" group will receive whichever of the five "atypical" antipsychotic medications they and their study doctor decide is best for them. Patients in the "oral" group will be allowed to switch to others of the five medications during the study if they and their doctor think that is best.

Patients in this study will be evaluated at the beginning of the study and then again every two weeks for up to 30 months (2 1/2 years). Each two-week visit will take about 20 minutes. At the visit, patients will receive medication and will be examined for side effects of the medications, their vital signs (heart rate, blood pressure, weight, and waist measurement) will be measured, and they will be asked a few questions about attendance at visits and taking medication. The visit that occurs every three months will take about one hour, instead of 20 minutes, and will include additional questions, an examination for muscle stiffness or abnormal body movements, and an interview from a member of the research team conducted using computer technology. In addition, blood and urine samples may be collected about seven times throughout the 30 months of the study treatment. Patients who enroll in this study after the halfway point of the study, may not receive a full 30 months of treatment, but it is planned that all patients will have the opportunity to receive no less than 18 months of treatment.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Injectable

Participants assigned to receive long-acting injectable risperidone

Group Type EXPERIMENTAL

Risperidone microspheres

Intervention Type DRUG

Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

Oral

Participants assigned to receive oral "atypical" antipsychotic medication

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Target dose is 4 mg/day.

Olanzapine

Intervention Type DRUG

Target dose is 15 mg/day.

Quetiapine

Intervention Type DRUG

Target dose is 600 mg/day.

Ziprasidone

Intervention Type DRUG

Target dose is 120 mg/day.

Aripiprazole

Intervention Type DRUG

Target dose is 20 mg/day.

Paliperidone

Intervention Type DRUG

Target dose is 6 mg/day.

Interventions

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Risperidone microspheres

Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

Intervention Type DRUG

Risperidone

Target dose is 4 mg/day.

Intervention Type DRUG

Olanzapine

Target dose is 15 mg/day.

Intervention Type DRUG

Quetiapine

Target dose is 600 mg/day.

Intervention Type DRUG

Ziprasidone

Target dose is 120 mg/day.

Intervention Type DRUG

Aripiprazole

Target dose is 20 mg/day.

Intervention Type DRUG

Paliperidone

Target dose is 6 mg/day.

Intervention Type DRUG

Other Intervention Names

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Risperdal Consta Risperdal Zyprexa Seroquel Geodon Abilify Invega

Eligibility Criteria

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Inclusion Criteria

* All schizophrenia and schizoaffective patients whose clinicians are considering long-term treatment with an "atypical" (second generation) antipsychotic medication
* Worsening of illness (schizophrenia) within 12 months of study entry as defined by: hospitalization, increased level of clinical care, and/or present clinical Global Impressions Severity rating of moderate or worse

Exclusion Criteria

* First episode patients as defined by a patient who: has never received antipsychotic medication and has never been hospitalized for psychiatric illness; or, is receiving antipsychotic medication for the first time associated with a first diagnosis of schizophrenia.
* Pregnant or breastfeeding
* Patients with unstable medical conditions
* Patients with previous history of failure to respond to an adequate trial of clozapine
* Patients with a known allergy to risperidone or a previous history of failure to respond to an adequate trial of risperidone. However, patients with known allergies or failure to respond to any of the other medications (aripiprazole, olanzapine, quetiapine or ziprasidone) will not receive that medication if they are randomized to the oral medication arm, but are not excluded from the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina R. Schooler, PhD

Role: STUDY_DIRECTOR

Steering and Implementation Center

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Medical College of Georgia, Department of Psychiatry

Augusta, Georgia, United States

Site Status

University of Iowa College of Medicine, Psychiatry Research

Iowa City, Iowa, United States

Site Status

Harvard Medical School -- Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center

Fall River, Massachusetts, United States

Site Status

Creighton University

Omaha, Nebraska, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Countries

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United States

References

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Buckley PF, Schooler NR, Goff DC, Hsiao J, Kopelowicz A, Lauriello J, Manschreck T, Mendelowitz AJ, Miller del D, Severe JB, Wilson DR, Ames D, Bustillo J, Mintz J, Kane JM; PROACTIVE Study. Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study. Schizophr Bull. 2015 Mar;41(2):449-59. doi: 10.1093/schbul/sbu067. Epub 2014 May 27.

Reference Type RESULT

PMID: 24870446 (View on PubMed)