Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

NCT ID: NCT00290121

Last Updated: 2013-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Olanzapine

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Interventions

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Olanzapine

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

OTHER

Sponsor Role collaborator

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

OTHER

Sponsor Role collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Stip, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche Fernand-Seguin, Université de Montréal

Locations

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Centre de recherche Fernand-Seguin

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Orban P, Desseilles M, Mendrek A, Bourque J, Bellec P, Stip E. Altered brain connectivity in patients with schizophrenia is consistent across cognitive contexts. J Psychiatry Neurosci. 2017 Jan;42(1):17-26. doi: 10.1503/jpn.150247.

Reference Type DERIVED
PMID: 27091719 (View on PubMed)

Stip E, Lungu OV. Salience network and olanzapine in schizophrenia: implications for treatment in anorexia nervosa. Can J Psychiatry. 2015 Mar;60(3 Suppl 2):S35-9.

Reference Type DERIVED
PMID: 25886678 (View on PubMed)

Stip E, Lungu OV, Anselmo K, Letourneau G, Mendrek A, Stip B, Lipp O, Lalonde P, Bentaleb LA. Neural changes associated with appetite information processing in schizophrenic patients after 16 weeks of olanzapine treatment. Transl Psychiatry. 2012 Jun 19;2(6):e128. doi: 10.1038/tp.2012.53.

Reference Type DERIVED
PMID: 22714121 (View on PubMed)

Other Identifiers

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2005-0503

Identifier Type: -

Identifier Source: org_study_id

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