Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
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|ClinicalTrials.gov Identifier: NCT00056498|
Recruitment Status : Completed
First Posted : March 17, 2003
Results First Posted : July 16, 2012
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Placebo Drug: Risperdal||Phase 4|
Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy.
Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clozapine Treatment of Schizophrenic Patients|
|Study Start Date :||December 2001|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
Active Comparator: Active
Participants assigned to risperidone
Risperdal 4 mg per day for 16 weeks
Other Name: Risperidone
Placebo Comparator: Placebo
Participants assigned to placebo
Placebo capsule daily for 16 weeks
- Positive Symptom Item Scores by Week and Treatment Group [ Time Frame: Baseline and every two weeks for 16 weeks. ]The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change.
- Neuropsychological Testing - Overall Composite Z-score [ Time Frame: Baseline and Week 16 ]The neuropsychological testing measured attention, executive function/problem solving, motor speed, processing speed/response generation, and verbal, visual, and working memory. The individual test raw scores were converted to z-scores and an overall composite z-score was computed from the average of the individual test z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance.
- Negative Symptom Total Score by Week and Treatment Group [ Time Frame: Baseline and every two weeks for 16 weeks. ]The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056498
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||Robert W Buchanan, MD||University of Maryland|