Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
PROACTIVE
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)
10 other identifiers
interventional
357
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started May 2006
Longer than P75 for phase_4 schizophrenia
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 26, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
July 10, 2018
CompletedJuly 10, 2018
June 1, 2018
4.7 years
May 26, 2006
September 4, 2015
June 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Substantial Clinical Deterioration Measured by Psychotic Symptoms
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 Outcomes (5)
Number of Patients Discontinuing From the Study
Measured throughout study up to 30 months
Number of Days in Hospital
Measured throughout study up to 30 months
Control of Psychiatric Symptoms
Measured throughout study up to 30 months
Quality of Life Measures
Measured throughout study up to 30 months
Side Effects and Metabolic Measures
Measured throughout study up to 30 months
Study Arms (2)
Injectable
EXPERIMENTALParticipants assigned to receive long-acting injectable risperidone
Oral
ACTIVE COMPARATORParticipants assigned to receive oral "atypical" antipsychotic medication
Interventions
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (8)
University of California, Los Angeles
Los Angeles, California, 91344, United States
Medical College of Georgia, Department of Psychiatry
Augusta, Georgia, 30912-3800, United States
University of Iowa College of Medicine, Psychiatry Research
Iowa City, Iowa, 52242, United States
Harvard Medical School -- Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center
Fall River, Massachusetts, 02720, United States
Creighton University
Omaha, Nebraska, 68131, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
The Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Related Publications (1)
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.
PMID: 24870446RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter F. Buckley, MD
- Organization
- Medical College of Georgia, Georgia Regents University
Study Officials
- STUDY DIRECTOR
Nina R. Schooler, PhD
Steering and Implementation Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2006
First Posted
May 29, 2006
Study Start
May 1, 2006
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
July 10, 2018
Results First Posted
July 10, 2018
Record last verified: 2018-06