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Clinical Trials/NCT00290121
NCT00290121
Completed
Phase 4

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

Université de Montréal1 site in 1 country25 target enrollmentSeptember 2006
ConditionsSchizophrenia
InterventionsOlanzapine

Overview

Phase
Phase 4
Intervention
Olanzapine
Conditions
Schizophrenia
Sponsor
Université de Montréal
Enrollment
25
Locations
1
Primary Endpoint
fMRI (functional magnetic resonance imaging with appetizing films)
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
June 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Olanzapine

Intervention: Olanzapine

Outcomes

Primary Outcomes

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 Outcomes

  • Abdominal circumference(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)
  • Age(16 weeks after beginning of Olanzapine treatment)
  • Sexe(16 weeks after beginning of Olanzapine treatment)
  • Weight(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)

Study Sites (1)

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