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| Sponsor: | Mclean Hospital |
|---|---|
| Information provided by: | Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00567034 |
Purpose
The main purpose of this study is to determine whether the opioid antagonist naltrexone is helpful in ameliorating the weight gain and other adverse metabolic side effects experienced by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa. Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa will normalize subjective pain ratings. Our tertiary objective is to examine the safety and tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Psychotic Disorders |
Drug: naltrexone Drug: placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Augmenting Zyprexa With Naltrexone: Normalization of the Weight Gain Side Effect and the CNS Reward and Sensory Function |
| Estimated Enrollment: | 52 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
taking naltrexone
|
Drug: naltrexone
50mg naltrexone, 1 tablet a day for 12 weeks.
|
|
Placebo Comparator: 2
taking placebo
|
Drug: placebo
lactose placebo, 1 capsule every day for 12 weeks
|
Zyprexa is one of the most commonly prescribed second generation antipsychotic drugs (SGAs), but its (and other SGA's) side effects contribute to the development of obesity and to the "Metabolic Syndrome." Both conditions, which are more prevalent even in unmedicated schizophrenic patients, are associated with increased cardiovascular morbidity and mortality. The mechanisms of these side effects are likely to be multifactorial and to involve peripheral and central factors alike. The present proposal asks a fundamental question: How the endogenous opioidergic systems are involved in Zyprexa-induced obesity and in related metabolic disturbances. We further hypothesize that if the excess of central opioid activity creates metabolic problems for patients, it is reasonable to expect amelioration of the symptoms through blockade of opioid receptors. The proposed project is designed to test this hypothesis by complimenting clinical psychopharmacology with pain medicine research and functional magnetic resonance imaging (fMRI) to empirically measure clinical outcomes of Zyprexa pharmacotherapy augmentation with the opioid receptor antagonist, naltrexone. Our objectives and hypotheses are as follows: to determine the effects of naltrexone on weight gain, metabolic (e.g., cholesterol, lipids, insulin, leptin and glucose levels), anthropometric and nutritional characteristics in Zyprexa treated schizophrenic patients, to examine the effects of naltrexone on subjective pain ratings, and to investigate the safety and tolerability of naltrexone in Zyprexa-treated schizophrenic patients.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret R Oliner, B.A. | 617-855-2891 | moliner@mclean.harvard.edu |
| United States, Massachusetts | |
| McLean Hospital | Recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Contact: Margaret R Oliner, B.A. 617-855-2891 moliner@mclean.harvard.edu | |
| Principal Investigator: Igor Elman, M.D. | |
| Principal Investigator: | Igor Elman, M.D. | Mclean Hospital |
More Information
| Responsible Party: | Igor Elman, M.D., McLean Hospital |
| ClinicalTrials.gov Identifier: | NCT00567034 History of Changes |
| Other Study ID Numbers: | 2006-P-0002381/3, F1D-US-X306 |
| Study First Received: | December 3, 2007 |
| Last Updated: | April 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Zyprexa naltrexone schizophrenia Metabolic Syndrome pain |
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Naltrexone Olanzapine Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Gastrointestinal Agents |