Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Recurrence; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Risperidone microspheres; Risperidone; Olanzapine; Quetiapine; Ziprasidone; Aripiprazole; Paliperidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.; Target dose is 4 mg/day.; Target dose is 15 mg/day.; Target dose is 600 mg/day.; Target dose is 120 mg/day.; Target dose is 20 mg/day.; Target dose is 6 mg/day.
Other intervention name(s): Risperdal Consta; Risperdal; Zyprexa; Seroquel; Geodon; Abilify; Invega
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; Prevention; Schizophrenia; Injectable Medication