Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

This study has been completed.
Sponsor:
Collaborators:
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Hopital du Sacre-Coeur de Montreal
Eli Lilly and Company
Information provided by (Responsible Party):
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00290121
First received: February 8, 2006
Last updated: March 13, 2013
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • fMRI (functional magnetic resonance imaging with appetizing films) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Ghrelin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Endogenous cannabinoids [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • PANSS (Positive and negative syndrome scale) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • CDSS (Calgary Depression scale for schizophrenia) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Three factors eating questionnaire [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Fagerstrom test for nicotine dependence [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Adult ADHD (attention deficit hyperactivity disorder) self report scale [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Age [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Sexe [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Abdominal circumference [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Number and times of hospitalization [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Prolactin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Onset of disease [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
  • Level of education [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olanzapine Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290121

Locations
Canada, Quebec
Centre de recherche Fernand-Seguin
Montréal, Quebec, Canada, H1N 3V2
Sponsors and Collaborators
Université de Montréal
Centre de recherche Fernand-Seguin, Hôpital Louis-H. Lafontaine
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Hopital du Sacre-Coeur de Montreal
Eli Lilly and Company
Investigators
Principal Investigator: Emmanuel Stip, MD, M.Sc. Centre de recherche Fernand-Seguin, Université de Montréal
  More Information

No publications provided by Université de Montréal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Université de Montréal
ClinicalTrials.gov Identifier: NCT00290121     History of Changes
Other Study ID Numbers: 2005-0503
Study First Received: February 8, 2006
Last Updated: March 13, 2013
Health Authority: Canada: Santé Canada

Keywords provided by Université de Montréal:
Schizophrenia
Atypical antipsychotics
Weight gain
Appetite
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014