Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00330863
  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 IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Olanzapine Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate Aripiprazole Paliperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

Further study details as provided by National Institute of Mental Health (NIMH):

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: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Injectable: Experimental
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.
Oral: Active Comparator
Participants assigned to receive oral "atypical" antipsychotic medication
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.

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

Contacts
Contact: Susan E. Ray, MS, CCRC 718-470-8442 SRay@lij.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 91344
Contact: Richard L Franco     818-832-2505     RLFranco@mednet.ucla.edu    
Contact: Brenda V Alvarez     818-832-2505     brenda.v.alvarez@gmail.com    
Principal Investigator: Alex Kopelowicz, M.D.            
United States, Georgia
Medical College of Georgia, Department of Psychiatry Recruiting
Augusta, Georgia, United States, 30912-3800
Contact: Dawn Montoya, B.S.     706-721-0409     dmontoya@mcg.edu    
Contact: Rebecca Nichols, B.S.     706-721-4605     rnichols@mcg.edu    
Principal Investigator: Peter F. Buckley, M. D.            
United States, Iowa
University of Iowa College of Medicine, Psychiatry Research Recruiting
Iowa City, Iowa, United States, 52242
Contact: Tim Holman, M.A.     319-335-6769     timothy-holman@uiowa.edu    
Contact: Jane Kerr, B.S.     319-353-4955     jane-kerr@uiowa.edu    
Principal Investigator: Del D. Miller, PharmD, M.D.            
United States, Massachusetts
Harvard Medical School -- Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lisa H. Raeke, M.A.     617-912-7840     LRaeke@partners.org    
Contact: Kelsey Shannahan, B.A.     617-912-7868     kshannahan@partners.org    
Principal Investigator: Donald Goff, M.D.            
Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Samantha S O'Connell, M.A.     508-235-7343     SSamberg@bidmc.harvard.edu    
Contact: Amanda Fennessey, B.A.     508-235-7299     AFenness@bidmc.harvard.edu    
Principal Investigator: Theo Manschreck, M.D.            
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
Contact: Kim A. Carroll, B.A.     402-345-8828 ext 22     KCarroll@creighton.edu    
Contact: Wendy Taylor     402-345-8828 ext 20     wtaylor@creighton.edu    
Principal Investigator: Daniel R. Wilson, M.D., Ph.D.            
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Heather Hawk, CPhT     505-272-9552     hhawk@salud.unm.edu    
Contact: Tara Biehl, M.S., CPhT     505-272-9544     tbiehl@salud.unm.edu    
Principal Investigator: John Lauriello, M.D.            
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Susan E. Ray, M.S., CCRC     718-470-8442     SRay@lij.edu    
Contact: Christopher M. Phillips, R.N.     718-470-8163     CPhillip@lij.edu    
Principal Investigator: Alan Mendelowitz, M.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: John M. Kane, MD Steering and Implementation Center
Study Director: Nina R. Schooler, PhD Steering and Implementation Center
Study Director: Stephen R. Marder, MD Steering and Implementation Center
  More Information

Responsible Party: North Shore Long Island Jewish Health System ( John M. Kane, MD )
Study ID Numbers: U01 MH 070007-01A2, U01 MH070023, U01 MH070011, U01 MH070009, U01 MH070008, U01 MH070017, UO1 MH070010, U01 MH070016, U01 MH070012, DSIR 83-ATAP
Study First Received: May 26, 2006
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00330863  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Relapse
Prevention
Schizophrenia
Injectable Medication

Study placed in the following topic categories:
Olanzapine
Risperidone
9-hydroxy-risperidone
Recurrence
Serotonin
Schizophrenia
Quetiapine
Dopamine
Mental Disorders
Psychotic Disorders
Aripiprazole
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Disease Attributes
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009