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

Schizophrenia Clinical Trial

— PROACTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330863
• Other study ID #: U01MH070007-01
• Secondary ID: U01MH070007-01U0
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: January 2011

Study information

• Verified date: June 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Recurrence
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Risperidone microspheres
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
• Risperidone
Target dose is 4 mg/day.
• Olanzapine
Target dose is 15 mg/day.
• Quetiapine
Target dose is 600 mg/day.
• Ziprasidone
Target dose is 120 mg/day.
• Aripiprazole
Target dose is 20 mg/day.
• Paliperidone
Target dose is 6 mg/day.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Medical College of Georgia, Department of Psychiatry	Augusta	Georgia
United States	Harvard Medical School -- Massachusetts General Hospital	Boston	Massachusetts
United States	Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center	Fall River	Massachusetts
United States	The Zucker Hillside Hospital	Glen Oaks	New York
United States	University of Iowa College of Medicine, Psychiatry Research	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Patients Discontinuing From the Study		Measured throughout study up to 30 months
Secondary	Number of Days in Hospital		Measured throughout study up to 30 months
Secondary	Control of Psychiatric Symptoms	Brief Psychiatric Rating Scale (BPRS) total score	Measured throughout study up to 30 months
Secondary	Quality of Life Measures	Scale of Functioning (SOF)	Measured throughout study up to 30 months
Secondary	Side Effects and Metabolic Measures	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