Status:
COMPLETED
Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
Detailed Description
A significant number of schizophrenics exhibit partial or no response to typical antipsychotic medications. Clozapine has been shown to be more effective in treating schizophrenia than typical antipsy...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia according to DSM-IV criteria
- Any schizoaffective disorder or subtype
- Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
- Currently taking clozapine
- Score of four or higher on two or more items from the positive symptom subscale of the PANSS
- Score of 4 or greater on the Clinical Global Impression (CGI) scale
- Clozapine plasma level greater than 378 µg/ml
- Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
- Able to read at an 8th grade level or above
Exclusion
- History of unstable coronary artery disease
- Congestive heart failure
- History of long Q-T syndrome
- History of cardiac arrhythmia
- History of cardiac conduction delay
- Baseline QT correction score greater than 0.425 seconds
- Liver disease
- History of stroke
- History of Neuroleptic Malignant Syndrome
- Hypokalemia
- Hypocalcemia
- Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
- Current suicidal or homicidal thoughts
- Currently abusing psychoactive substances
- Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00158223
Start Date
October 1 2004
End Date
February 1 2009
Last Update
April 9 2015
Active Locations (3)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
Manhattan Psychiatric Center
New York, New York, United States, 10035
3
Pilgrim Psychiatric Center
W. Brentwood, New York, United States, 11717