Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222833
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 15, 2008
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of Pittsburgh

Brief Summary:
This is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to aripiprazole with respect to changes in the clinical state, preexisting or emergent side-effects, how the brain processes information and changes in social functioning and quality of life.

Condition or disease Intervention/treatment Phase
Overweight Hyperlipidemia Cardiovascular Diseases Drug: Aripiprazole Phase 4

Detailed Description:
This is a 2-yr study proposing to examine the effects of switching subjects from conventional and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in overweight and obese patients with Schizophrenia or Schizoaffective disorder. Thirty partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined cross-tapering approach.The objective of the study is to examine cardiovascular health indices such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to Aripiprazole with respect to changes in clinical state, preexisting or emergent side-effects, how brain processes information and changes in social functioning and quality of life.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia
Study Start Date : October 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure

Secondary Outcome Measures :
  1. Changes in clinical state
  2. Pre-existing or emergent side effects
  3. Cognition and insight
  4. Attitude towards medication
  5. Social functioning
  6. Quality of life


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects ages 18-65 years
  • Outpatients and stable partial hospital patients
  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
  • No psychiatric hospitalization in 30 days prior to study start
  • Partially remitted patients with a PANSS score below 100 at screening
  • Currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
  • Currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
  • BMI greater than 26
  • Female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Mental retardation
  • Current treatment with clozapine
  • Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
  • Serious or unstable medical illness
  • Female patients who are pregnant, lactating, or plan to become pregnant during the study period
  • Concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222833


Locations
Layout table for location information
United States, Pennsylvania
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Rohan Ganguli, MD University of Pittsburgh
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00222833    
Other Study ID Numbers: 0312010
PITT#02 90599
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by University of Pittsburgh:
Schizophrenia
Schizoaffective disorder
Aripiprazole
Obese
Overweight
Heart Health
Antipsychotic
Heart Health Factors
Cardiovascular Health Indices
Cardiovascular health
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Hyperlipidemias
Overweight
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists