NCT00330863

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Risperidone microspheres	Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
DRUG	Risperidone	Target dose is 4 mg/day.
DRUG	Olanzapine	Target dose is 15 mg/day.
DRUG	Quetiapine	Target dose is 600 mg/day.
DRUG	Ziprasidone	Target dose is 120 mg/day.
DRUG	Aripiprazole	Target dose is 20 mg/day.
DRUG	Paliperidone	Target dose is 6 mg/day.

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2006-05-29
• Last updated: 2018-07-10
• Results posted: 2018-07-10

Locations

8 sites across 1 country: United States