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Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
This study is currently recruiting participants.
Verified by University of Montreal, October 2005
Sponsors and Collaborators: University of Montreal
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Institut Universitaire de Gériatrie de Montréal
Hôpital du Sacré-Coeur de Montréal
Eli Lilly and Company
Information provided by: University of Montreal
ClinicalTrials.gov Identifier: NCT00290121
  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 IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)

Further study details as provided by University of Montreal:

Primary Outcome Measures:
  • fMRI with appetizing films
  • Weight

Secondary Outcome Measures:
  • Fasting glucose
  • Insulin
  • Leptin
  • Ghrelin
  • Endogenous cannabinoids
  • Lipid profile
  • PANSS (Positive and negative syndrome scale)
  • CDSS (Calgary Depression scale for schizophrenia)
  • Three factors eating questionnaire
  • Fagerstrom test for nicotine dependence
  • Adult ADHD self report scale
  • Age
  • Sexe
  • Weight
  • Abdominal circumference
  • Number and times of hospitalization
  • Blood pressure
  • Prolactin
  • Onset of disease
  • Level of education

Estimated Enrollment: 30
Study Start Date: September 2005
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290121

Contacts
Contact: Emmanuel Stip, MD, M.Sc 514-251-4015 ext 3396 emmanuel.stip@umontreal.ca

Locations
Canada, Quebec
Centre de recherche Fernand-Seguin Recruiting
Montréal, Quebec, Canada, H1N 3V2
Principal Investigator: Emmanuel Stip, MD, M.Sc            
Sponsors and Collaborators
University of Montreal
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Institut Universitaire de Gériatrie de Montréal
Hôpital du Sacré-Coeur de Montréal
Eli Lilly and Company
Investigators
Principal Investigator: Emmanuel Stip, MD, M.Sc. Centre de recherche Fernand-Seguin, Université de Montréal
  More Information

Study ID Numbers: 2005-0503
Study First Received: February 8, 2006
Last Updated: February 8, 2006
ClinicalTrials.gov Identifier: NCT00290121  
Health Authority: Canada: Santé Canada

Keywords provided by University of Montreal:
Schizophrenia
Atypical antipsychotics
Weight gain
Appetite
fMRI

Study placed in the following topic categories:
Schizophrenia
Body Weight
Mental Disorders
Olanzapine
Psychotic Disorders
Weight Gain
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009