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Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290121
First Posted: February 10, 2006
Last Update Posted: March 14, 2013
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.
Collaborators:
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Hopital du Sacre-Coeur de Montreal
Eli Lilly and Company
Information provided by (Responsible Party):
Université de Montréal
  Purpose
The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.

Condition Intervention Phase
Schizophrenia Drug: Olanzapine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • fMRI (functional magnetic resonance imaging with appetizing films) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Insulin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Leptin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Ghrelin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Endogenous cannabinoids [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Lipid profile [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • PANSS (Positive and negative syndrome scale) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • CDSS (Calgary Depression scale for schizophrenia) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Three factors eating questionnaire [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Fagerstrom test for nicotine dependence [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Adult ADHD (attention deficit hyperactivity disorder) self report scale [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Age [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Sexe [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Abdominal circumference [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Number and times of hospitalization [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Blood pressure [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Prolactin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Onset of disease [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]
  • Level of education [ Time Frame: 16 weeks after beginning of Olanzapine treatment ]

Enrollment: 25
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olanzapine Drug: Olanzapine

Detailed Description:

Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are considered to be more effective in reducing positive and negative symptoms and in improving cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than typical antipsychotics. They still have a lot of important side effects like sedation, metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and cardiovascular diseases, particularly for schizophrenia patients because they are already at an increased risk for these complications. Moreover, an increase in weight gain has been demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent risk of relapse. It also can create an additional social disadvantage for schizophrenia patients and decrease their quality of life. The weight gain will result, in part from an increased food intake (and probably an increased appetite) and from a decreased energy expenditure.

The purpose of this study is to understand the cerebral mechanisms of appetite in patients with schizophrenia treated with atypical antipsychotics to prevent or treat their weight gain.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with schizophrenia (DMS-IV)
  • 18 to 60 years old
  • Right handed
  • Begin a treatment with olanzapine and had not received it for at leat 6 months
  • Other medication accepted (except antipsychotic)

Exclusion Criteria:

  • concomitant axis-I or axis-II disorders
  • unstable medical condition
  • Concomitant antipsychotic medications
  Contacts and Locations
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): NCT00290121


Locations
Canada, Quebec
Centre de recherche Fernand-Seguin
Montréal, Quebec, Canada, H1N 3V2
Sponsors and Collaborators
Université de Montréal
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Hopital du Sacre-Coeur de Montreal
Eli Lilly and Company
Investigators
Principal Investigator: Emmanuel Stip, MD, M.Sc. Centre de recherche Fernand-Seguin, Université de Montréal
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Université de Montréal
ClinicalTrials.gov Identifier: NCT00290121     History of Changes
Other Study ID Numbers: 2005-0503
First Submitted: February 8, 2006
First Posted: February 10, 2006
Last Update Posted: March 14, 2013
Last Verified: October 2005

Keywords provided by Université de Montréal:
Schizophrenia
Atypical antipsychotics
Weight gain
Appetite
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents