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Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
This study is ongoing, but not recruiting participants.
First Received: August 17, 2005   Last Updated: January 6, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00132314
  Purpose

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.


Condition Intervention Phase
Schizoaffective Disorder
Schizophrenia
Drug: IM risperidone
Drug: oral antipsychotic medication
Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Time to re-hospitalization [ Time Frame: monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: September 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
long-acting injectable risperidone
Drug: IM risperidone
long-acting injectable risperidone
2: Active Comparator
oral antipsychotic medication
Drug: oral antipsychotic medication
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132314

  Show 19 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Robert A. Rosenheck, AB MD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Rosenheck, Robert - Study Chair )
Study ID Numbers: 555
Study First Received: August 17, 2005
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00132314     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009