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Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de recherche Fernand-Seguin

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Olanzapine

Arm Description

Outcomes

Primary Outcome Measures

fMRI (functional magnetic resonance imaging with appetizing films)
Weight

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2006
Last Updated
March 13, 2013
Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Hopital du Sacre-Coeur de Montreal, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00290121
Brief Title
Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
Official Title
Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Hopital du Sacre-Coeur de Montreal, Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
fMRI (functional magnetic resonance imaging with appetizing films)
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Weight
Time Frame
16 weeks after beginning of Olanzapine treatment
Secondary Outcome Measure Information:
Title
Fasting glucose
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Insulin
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Leptin
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Ghrelin
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Endogenous cannabinoids
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Lipid profile
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
PANSS (Positive and negative syndrome scale)
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
CDSS (Calgary Depression scale for schizophrenia)
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Three factors eating questionnaire
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Fagerstrom test for nicotine dependence
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Adult ADHD (attention deficit hyperactivity disorder) self report scale
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Age
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Sexe
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Weight
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Abdominal circumference
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Number and times of hospitalization
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Blood pressure
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Prolactin
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Onset of disease
Time Frame
16 weeks after beginning of Olanzapine treatment
Title
Level of education
Time Frame
16 weeks after beginning of Olanzapine treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Stip, MD, M.Sc.
Organizational Affiliation
Centre de recherche Fernand-Seguin, Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche Fernand-Seguin
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27091719
Citation
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.
Results Reference
derived
PubMed Identifier
25886678
Citation
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.
Results Reference
derived
PubMed Identifier
22714121
Citation
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.
Results Reference
derived

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Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

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