- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00224822
The Effects of Aripiprazole on Patients With Metabolic Syndrome
March 23, 2010 updated by: New Mexico VA Healthcare System
The Effects of Aripiprazole on Patients With "Metabolic Syndrome": An Open-Label Trial
The primary goal of this study is to assess the effect of aripiprazole on patients who developed metabolic syndrome while taking other second generation antipsychotic medications.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Schizophrenia, schizoaffective disorder and bipolar disorder are severe and disabling disorders, associated with marked social or occupational dysfunction, tenfold suicidal risk, intensive healthcare resource utilization and poor prognosis.
Atypical antipsychotics developed in the last decade are proving beneficial to a subset of patients.
These agents share a reduced risk for EPS and tardive dyskinesia in comparison with first generation antipsychotics.
They also appear to improve negative, cognitive, and depressive symptoms while being at least as efficacious as first generation "typical" drugs in controlling positive symptoms of schizophrenia and schizoaffective disorder.
Unfortunately, during the late 1990's, case reports and studies began to document a number of adverse events associated with the use of most second generation antipsychotics such as weight gain, hyperlipidemia and hyperglycemia subsumed under the name "metabolic syndrome".
Aripiprazole has a unique pharmacological mechanism, making this drug the ideal medication for treatment to patients who experience metabolic syndrome from other second generation antipsychotics.
In numerous pervious trials, it has been demonstrated that aripiprazole is a safe and effective treatment for schizophrenia, schizoaffective disorder and bipolar disorder and that it may actually reduce plasma glucose levels and improve lipid profiles, lowering the risk for cardiovascular disease and /or diabetes.
Thirty patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder who have experienced a 10 pound increase in weight while on a second generation antipsychotic or hyperlipidemia, or hyperglycemia, will switch to aripiprazole and be monitored for any improvement in BMI, lipids and glucose.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- New Mexico VA Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females with DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who, based on chart review, have developed significant weight gain or any clinically significant aspect of the metabolic syndrome including weight gain, hyperglycemia, diabetes, or hyperlipidemia, while on a second generation antipsychotic medication.
- Between 18-65 years of age
- Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker.
- If female, must agree to use a medically approved contraceptive or does not possess potential to bear children
Exclusion Criteria:
- History of adverse reaction to aripiprazole
- Serious hepatic, renal, cardiac, neurological, or pulmonary disease that would prevent safe participation in a drug trial
- A diagnosis of active drug or alcohol abuse according to DSM-IV criteria within the last 30 days
- Suicidal or homicidal ideation or psychotic decompensation
- Patients on Paxil, Remeron, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants or mood stabilizers other than lamotrigine.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome assessment is weight gain/body mass index (BMI) compared to baseline
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Other primary outcomes with regard to efficacy will be scores on the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impressions (CGI) compared to baseline.
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Secondary Outcome Measures
Outcome Measure |
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Fasting lipids, glucose profiles and electrocardiogram (EKG) results compared to baseline to assess glucose, weight, lipids, and heart rhythms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Geppert, MD, PhD, New Mexico VA Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
September 21, 2005
First Submitted That Met QC Criteria
September 21, 2005
First Posted (Estimate)
September 23, 2005
Study Record Updates
Last Update Posted (Estimate)
March 24, 2010
Last Update Submitted That Met QC Criteria
March 23, 2010
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Schizophrenia Spectrum and Other Psychotic Disorders
- Insulin Resistance
- Hyperinsulinism
- Bipolar and Related Disorders
- Syndrome
- Schizophrenia
- Disease
- Psychotic Disorders
- Metabolic Syndrome
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- VA-0001
- BRINM #170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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