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Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00290121
Enrollment
25
Registered
2006-02-10
Start date
2006-09-30
Completion date
2008-06-30
Last updated
2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI

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.

Interventions

DRUGOlanzapine

Sponsors

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
CollaboratorOTHER
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
CollaboratorOTHER
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
CollaboratorOTHER
Eli Lilly and Company
CollaboratorINDUSTRY
Université de Montréal
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
fMRI (functional magnetic resonance imaging with appetizing films)16 weeks after beginning of Olanzapine treatment
Weight16 weeks after beginning of Olanzapine treatment

Secondary

MeasureTime frame
Leptin16 weeks after beginning of Olanzapine treatment
Ghrelin16 weeks after beginning of Olanzapine treatment
Endogenous cannabinoids16 weeks after beginning of Olanzapine treatment
Lipid profile16 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 questionnaire16 weeks after beginning of Olanzapine treatment
Fagerstrom test for nicotine dependence16 weeks after beginning of Olanzapine treatment
Adult ADHD (attention deficit hyperactivity disorder) self report scale16 weeks after beginning of Olanzapine treatment
Fasting glucose16 weeks after beginning of Olanzapine treatment
Sexe16 weeks after beginning of Olanzapine treatment
Weight16 weeks after beginning of Olanzapine treatment
Abdominal circumference16 weeks after beginning of Olanzapine treatment
Number and times of hospitalization16 weeks after beginning of Olanzapine treatment
Blood pressure16 weeks after beginning of Olanzapine treatment
Prolactin16 weeks after beginning of Olanzapine treatment
Onset of disease16 weeks after beginning of Olanzapine treatment
Level of education16 weeks after beginning of Olanzapine treatment
Age16 weeks after beginning of Olanzapine treatment
Insulin16 weeks after beginning of Olanzapine treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026