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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00330863
First received: May 26, 2006
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Risperidone microspheres
Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Ziprasidone
Drug: Aripiprazole
Drug: Paliperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Time to relapse, where "relapse" is defined as psychiatric hospitalization [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Increase in the level of psychiatric care required to avert hospitalization [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Substantial clinical deterioration measured by psychotic symptoms [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients discontinuing from the study [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Number of days in hospital [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Visits to hospital emergency rooms [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Control of psychiatric symptoms [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Quality of life measures [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
  • Side effects and metabolic measures [ Time Frame: Measured throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 304
Study Start Date: May 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Injectable
Participants assigned to receive long-acting injectable risperidone
Drug: Risperidone microspheres
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
Other Name: Risperdal Consta
Active Comparator: Oral
Participants assigned to receive oral "atypical" antipsychotic medication
Drug: Risperidone
Target dose is 4 mg/day.
Other Name: Risperdal
Drug: Olanzapine
Target dose is 15 mg/day.
Other Name: Zyprexa
Drug: Quetiapine
Target dose is 600 mg/day.
Other Name: Seroquel
Drug: Ziprasidone
Target dose is 120 mg/day.
Other Name: Geodon
Drug: Aripiprazole
Target dose is 20 mg/day.
Other Name: Abilify
Drug: Paliperidone
Target dose is 6 mg/day.
Other Name: Invega

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330863

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 91344
United States, Georgia
Medical College of Georgia, Department of Psychiatry
Augusta, Georgia, United States, 30912-3800
United States, Iowa
University of Iowa College of Medicine, Psychiatry Research
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Harvard Medical School -- Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center
Fall River, Massachusetts, United States, 02720
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Study Director: Nina R. Schooler, PhD Steering and Implementation Center
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00330863     History of Changes
Other Study ID Numbers: U01 MH070007-01, U01MH070007-01, U01MH070023, U01MH070011, U01MH070009, U01MH070008, U01MH070017, U01MH070010, U01MH070016, U01MH070012, DSIR 83-ATAP
Study First Received: May 26, 2006
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:
Relapse
Prevention
Schizophrenia
Injectable Medication

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
9-hydroxy-risperidone
Aripiprazole
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014