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

June 12, 2018 updated by: Northwell Health

Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 91344
        • University of California, Los Angeles
    • Georgia
      • Augusta, Georgia, United States, 30912-3800
        • Medical College of Georgia, Department of Psychiatry
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Medicine, Psychiatry Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard Medical School -- Massachusetts General Hospital
      • Fall River, Massachusetts, United States, 02720
        • Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Glen Oaks, New York, United States, 11004
        • The Zucker Hillside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injectable
Participants assigned to receive long-acting injectable risperidone
Drug: Risperidone microspheres
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
Other Names:
  • Risperdal Consta
Active Comparator: Oral
Participants assigned to receive oral "atypical" antipsychotic medication
Drug: Risperidone
Target dose is 4 mg/day.
Other Names:
  • Risperdal
Drug: Olanzapine
Target dose is 15 mg/day.
Other Names:
  • Zyprexa
Drug: Quetiapine
Target dose is 600 mg/day.
Other Names:
  • Seroquel
Drug: Ziprasidone
Target dose is 120 mg/day.
Other Names:
  • Geodon
Drug: Aripiprazole
Target dose is 20 mg/day.
Other Names:
  • Abilify
Drug: Paliperidone
Target dose is 6 mg/day.
Other Names:
  • Invega

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substantial Clinical Deterioration Measured by Psychotic Symptoms
Time Frame: Measured throughout study up to 30 months
Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.
Measured throughout study up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Discontinuing From the Study
Time Frame: Measured throughout study up to 30 months
Measured throughout study up to 30 months
Number of Days in Hospital
Time Frame: Measured throughout study up to 30 months
Measured throughout study up to 30 months
Control of Psychiatric Symptoms
Time Frame: Measured throughout study up to 30 months
Brief Psychiatric Rating Scale (BPRS) total score
Measured throughout study up to 30 months
Quality of Life Measures
Time Frame: Measured throughout study up to 30 months
Scale of Functioning (SOF)
Measured throughout study up to 30 months
Side Effects and Metabolic Measures
Time Frame: Measured throughout study up to 30 months
The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.
Measured throughout study up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Director: Nina R. Schooler, PhD, Steering and Implementation Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH070007-01 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAP (NIMH/DSIR)
  • U01MH070023 (U.S. NIH Grant/Contract)
  • U01MH070011 (U.S. NIH Grant/Contract)
  • U01MH070009 (U.S. NIH Grant/Contract)
  • U01MH070008 (U.S. NIH Grant/Contract)
  • U01MH070017 (U.S. NIH Grant/Contract)
  • U01MH070010 (U.S. NIH Grant/Contract)
  • U01MH070016 (U.S. NIH Grant/Contract)
  • U01MH070012 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Risperidone microspheres

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe