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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00158223 |
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia Psychotic Disorders |
Drug: Pimozide Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pimozide Augmentation of Clozapine in Schizophrenia |
Estimated Enrollment: | 64 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Participants will receive encapsulted placebo made to match active drug
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Drug: Placebo
Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There eill be felixble dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.
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1: Experimental
Participants will receive pimozide flexible dosing
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Drug: Pimozide
Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects.
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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 antipsychotic drugs. However, only an estimated 30% to 60% of people who are unresponsive to treatment with typical antipsychotics will respond to treatment with clozapine. Taking clozapine with pimozide, an antipsychotic drug, can increase clozapine's effects. However, sufficient research on this approach has not yet been performed. This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
Participants in this double-blind study will receive a stable dose of clozapine for eight weeks prior to enrollment. For the first 4 weeks following enrollment, baseline measurements will be taken. Once a week, participants will report to the study site, where symptom severity, cognitive ability, and functional status, including reading level, will be assessed. In addition, participants will receive a standard medical examination, which will include blood tests and an EKG. Upon completion of this initial phase, participants will be randomly assigned to one of two treatment groups: clozapine combined with pimozide; or clozapine combined with placebo. This phase will last for 12 weeks. Study visits will continue to occur weekly, and will be used to re-assess the measurements obtained during baseline. In addition, participants will have an EKG at each study visit for the first 4 weeks of treatment. All baseline measurements will be repeated in Week 12.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph I. Friedman, MD | 631-761-3607 |
United States, New York | |
The Mount Sinai Hospital | Recruiting |
New York, New York, United States, 10029 | |
Contact: Mariangela Cavagna 212-659-9223 mariangela.cavagna@mssm.edu | |
Principal Investigator: Joseph I. Friedman, MD | |
Pilgrim Psychiatric Center | Recruiting |
W. Brentwood, New York, United States, 11717 | |
Contact: Michelle Bergman 631-761-2717 PGMDMIL@omh.state.ny.us | |
Principal Investigator: Joseph I. Friedman, MD | |
Manhattan Psychiatric Center | Recruiting |
New York, New York, United States, 10035 | |
Contact: Frances Alcantara 646-672-6173 Marcffa@omh.state.ny.us | |
Principal Investigator: Jean-Pierre I. Lindenmayer, MD |
Principal Investigator: | Joseph I. Friedman, MD | Mount Sinai School of Medicine |
Responsible Party: | Mount Sinai School of Medicine ( Joseph I. Friedman ) |
Study ID Numbers: | R01 MH67806, DSIR 83-ATAP |
Study First Received: | September 7, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00158223 |
Health Authority: | United States: Federal Government |
Schizophrenia Clozapine Treatment |
Combination Unresponsive Schizoaffective Disorders |
Schizophrenia Dopamine Mental Disorders Clozapine |
Psychotic Disorders Pimozide Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions GABA Antagonists Serotonin Antagonists Serotonin Agents Therapeutic Uses GABA Agents Dopamine Agents Central Nervous System Agents |