Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

March 13, 2013 updated by: Université de Montréal

Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

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

    • Quebec
      • Montréal, Quebec, Canada, H1N 3V2
        • Centre de recherche Fernand-Seguin

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI (functional magnetic resonance imaging with appetizing films)
Time Frame: 16 weeks after beginning of Olanzapine treatment
16 weeks after beginning of Olanzapine treatment
Weight
Time Frame: 16 weeks after beginning of Olanzapine treatment
16 weeks after beginning of Olanzapine treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emmanuel Stip, MD, M.Sc., Centre de recherche Fernand-Seguin, Université de Montréal

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

September 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

October 1, 2005

More Information

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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