Clinical trial NCT00330863: Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Official title: Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Relapse
Prevention
Schizophrenia
Injectable Medication
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-05-29
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Substantial Clinical Deterioration Measured by Psychotic Symptoms
timeFrame: Measured throughout study up to 30 months
Secondary outcomes:
measure: Number of Patients Discontinuing From the Study
timeFrame: Measured throughout study up to 30 months
measure: Number of Days in Hospital
timeFrame: Measured throughout study up to 30 months
measure: Control of Psychiatric Symptoms
timeFrame: Measured throughout study up to 30 months
measure: Quality of Life Measures
timeFrame: Measured throughout study up to 30 months
measure: Side Effects and Metabolic Measures
timeFrame: Measured throughout study up to 30 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Augusta
country: United States
facility: Medical College of Georgia, Department of Psychiatry
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa College of Medicine, Psychiatry Research
state: Iowa
city: Boston
country: United States
facility: Harvard Medical School -- Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center
state: Massachusetts
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Steering and Implementation Center
name: Nina R. Schooler, PhD
role: STUDY_DIRECTOR
References:
citation: 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.