Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine

• Registration Number: NCT00290121
• Lead Sponsor: Université de Montréal

Brief Summary

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

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 Timeline

• Status Verified: 2005-10
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Study Start: 2006-09
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sexe	16 weeks after beginning of Olanzapine treatment
Weight	16 weeks after beginning of Olanzapine treatment
Age	16 weeks after beginning of Olanzapine treatment
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
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

Trial Locations

Locations (1)

Centre de recherche Fernand-Seguin; 🇨🇦 Montréal, Quebec, Canada