Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizoaffective Disorder; Schizophrenia
Intervention: IM risperidone (Drug); oral antipsychotic medication (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Robert A. Rosenheck, AB MD, Study Chair, Affiliation: VA Connecticut Health Care System (West Haven)
Overall contact:
Brandi Williams, BS, Phone: (203) 932-5711, Ext: 2563, Email: Brandi.Williams@va.gov
Summary
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least
one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly
assigned at 16 VA medical centers to long-acting injectible risperidone or doctor's choice of
oral antipsychotic medication (i. e., excluding other long-acting injectable medications, but
not specifying any particular oral agents or dosages). Recruitment would take 27 months to
complete, and the study would continue for a third year to allow 9 months of follow-up for
the last patient recruited. All patients would be treated from the time of entry up to the
end of the three-year study period. Follow-up assessments would continue quarterly.
Treatments would not be blinded since giving placebo injections to the comparison group would
interfere with the goal of comparing the acceptability of two different methods of medication
administration. However, end points will be blindly rated.
Clinical Details
Official title: CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to re-hospitalization
Detailed description:
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone
on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication
adherence, side effects, and health care costs.
Objectives:
Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of
inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment
in a randomized controlled trial to be conducted with 450 veterans diagnosed with
schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.
Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as
compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over
12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and
non-VA health service use and related costs, e) medication side effects, f) violent behavior,
g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18 years or older.
2. Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical
Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).
3. Patients should
1. have been hospitalized in the two years before study entry on a psychiatric
inpatient unit, or
2. document explicit current evidence of increased use of outpatient services such
as additional visits, day treatment or non-hospital residential treatment,
increased dosage of medications or addition of concomitant psychotropic
medications.
The b criterion will promptly be adjudicated by the study chairmen on a case-by case
basis to insure credibility.
4. .Adequate transportation is available and the participant lives within a travel time
of less than 1. 5 hours, allowing attendance at all scheduled visits.
5. Use of an acceptable method of birth control by female patients who have a possibility
of becoming pregnant (safety concerns).
6. Able to demonstrate decisional capacity in order to give informed consent as assessed
by the MacArthur Competence Assessment Tool (MacCAT) (Appelbaum and Grisso, 1996).
Guardian consent is acceptable where applicable.
7. Dually diagnosed patients with both schizophrenia and addictive disorders would be
included in this study but should not be in need of acute detoxification for
physiologic substance dependence (excluding nicotine) in the past 30 days.
Exclusion Criteria:
1. Physiologic substance dependence requiring detoxification (excluding nicotine) in the
past 30 days (substance abuse is not an exclusion).
2. Intolerance of risperidone.
3. Intolerance of intramuscular injection.
4. Current treatment with depot antipsychotic medication.
5. Current treatment with oral clozapine or presence of refractory schizophrenia that, in
the treating psychiatrist's opinion, requires clozapine.
6. Hepatic or renal problems AST or ALT (>2 times upper limit of normal);
7. Elevated bilirubin (>1. 2), BUN (>24), creatinine (>1. 7).
8. Unstable, serious medical condition or one requiring acute medical treatment, or
anticipation of hospitalization for extended care.
9. Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.
10. Unstable living arrangements or not planning to remain in the area for the next year.
11. Legal entanglements or pending legal charges with potential of incarceration.
12. Assault or suicide gesture currently needing acute intervention.
13. Concurrent participation in another clinical trial with an investigational drug during
the last 30 days.
14. Pregnant or lactating women or women planning to become pregnant.
Locations and Contacts
Brandi Williams, BS, Phone: (203) 932-5711, Ext: 2563, Email: Brandi.Williams@va.gov
VA Medical Center, Tuscaloosa, Tuscaloosa, Alabama 35404, United States; Recruiting
Linda Cheatum, Phone: --, Email: Linda.Cheatum@va.gov
VA Medical Center, Long Beach, Long Beach, California 90822, United States; Recruiting
Shirley Funnamark, Phone: --, Email: Shirley.Funnamark@va.gov
VA Palo Alto Health Care System, Palo Alto, California 94304-1290, United States; Recruiting
Rona Relova, Phone: --, Email: RonaMargaret.Relova@va.gov
VA Connecticut Health Care System (West Haven), West Haven, Connecticut 06516, United States; Recruiting
Brandi Williams, BS, Phone: 203-932-5711, Ext: 2563, Email: Brandi.Williams@va.gov
Robert A. Rosenheck, AB MD, Study Chair
VA Medical Center, Miami, Miami, Florida 33125, United States; Recruiting
Al Merchant, Phone: --, Email: AlKarim.Merchant@va.gov
VA Medical Center, Augusta, Augusta, Georgia 30904, United States; Terminated
Jesse Brown VAMC (WestSide Division), Chicago, Illinois 60612, United States; Recruiting
Melissa Chow, RN, Phone: --, Email: Melissa.Chow@va.gov
VA Medical Center, Jamaica Plain Campus, Boston, Massachusetts 02130, United States; Recruiting
Mark Zacheis, RN, Phone: --, Email: Mark.Zacheis@va.gov
John D. Dingell VA Medical Center, Detroit, Detroit, Michigan 48201, United States; Recruiting
Vicki Berchou, RN, Phone: --, Email: Vicki.Berchou@va.gov
VA Medical Center, Minneapolis, Minneapolis, Minnesota 55417, United States; Terminated
VA Medical Center, Kansas City MO, Kansas City, Missouri 64128, United States; Recruiting
Angela Witt, RN, Phone: --, Email: Angela.Witt@va.gov
VA Medical Center, Omaha, Omaha, Nebraska 68105-1873, United States; Terminated
New Mexico VA Health Care System, Albuquerque, Albuquerque, New Mexico 87108-5153, United States; Recruiting
Jose Canive, MD, Phone: --, Email: Jose.Canive@va.gov
New York Harbor HCS, New York, New York 10010, United States; Recruiting
Ms. Terry Leon, Phone: --, Email: Terry.Leon1@med.va.gov
VA Medical Center, Cleveland, Cleveland, Ohio 44106, United States; Recruiting
Virginia Nero, Phone: --, Email: Virginia.Nero@va.gov
VA Medical Center, Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Ayannah Fitzgerald, Phone: --, Email: Ayannah.Fitzgerald@va.gov
Michael E. DeBakey VA Medical Center (152), Houston, Texas 77030, United States; Recruiting
Curtis Griffin, Phone: 713-791-1414, Ext: 6694, Email: Curtis.Griffin@va.gov
Central Texas Veterans Health Care System - Waco, Waco, Texas 76711, United States; Recruiting
Christine Kuhn, Phone: --, Email: Christine.Kuhn@va.gov
VA Puget Sound Health Care System, Seattle, Seattle, Washington 98108, United States; Recruiting
Andre Tapp, MD, Phone: --, Email: Andre.Tapp@va.gov
Additional Information
Starting date: September 2006
Ending date: September 2009
Last updated: August 5, 2008
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