Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Olanzapine<br> | Drug: Olanzapine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI