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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Collaborators: |
Hoffmann-La Roche Shekhar, Anantha M.D., Ph.D. |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00216281 |
Purpose
This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total sample size of 126 subjects diagnosed with schizophrenia and being treated with the antipsychotic clozapine will undergo genotyping. These subjects will have an initial assessment at four weeks and regular follow-up assessments for a total period of 52 weeks. These subjects will be randomized to continued treatment with CLZ and augmentation with ATX or Placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Clozapine augmented with atomoxetine up to 40 mg or placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Correlation of Phenotype, Genotype and Clinical Efficacy/Toxicity of Clozapine Augmented by Atomoxetine for Treatment Refractory Schizophrenia (CAPG Study) |
| Estimated Enrollment: | 126 |
The purpose of this study is to scientifically explore the potential of pharmacogenetic applications as a means of predicting the clinical efficacy and safety of treatment with clozapine and atomoxetine in a treatment resistant schizophrenic population.
The principle enzyme involved in the metabolism of clozapine is CYP1A2 with minor contributions from CYP2D6. However, all the subjects will be on a stable dose of clozapine and will continue on the same dosage throughout the study. On the other hand, half the number of subjects will be randomized to augmentation with atomoxetine and since atomoxetine is predominantly metabolized by CYP2D6 with contributions from CYP2C19, we will focus on genetic variations for CYP2D6 and CYP2C19.
The goal of this study is to associate atomoxetine and metabolite drug concentrations with clinical efficacy and the development of any clinical adverse drug reactions and to determine whether clinical outcome (efficacy and ADRs) experienced following drug ingestion are more likely to be seen in patients who manifest CYP2D6 and/or CYP2C19 polymorphism(s). Other indications for pharmacogenetics in patient care, relevance of therapeutic drug monitoring, augmentation strategies and dosage guidelines may be generated from the experience and results of this study.
Primary Objectives
Secondary Objectives
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stable on clozapine treatment. Criteria for stability defined as follows:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| LaRue Carter Hospital | |
| Indianapolis, Indiana, United States, 46222 | |
| Principal Investigator: | Anantha Shekhar, MD, PhD | Indiana University School of Medicine |
More Information
| ClinicalTrials.gov Identifier: | NCT00216281 History of Changes |
| Other Study ID Numbers: | 0501-47 |
| Study First Received: | September 19, 2005 |
| Last Updated: | June 20, 2007 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Schizophrenia Clozapine Atomoxetine |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Atomoxetine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Uptake Inhibitors |