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Completed

NCT Number: NCT00290121

Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre de recherche Fernand-Seguin

Montreal, Quebec, H1N 3V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

Primary outcomes

  1. fMRI (functional magnetic resonance imaging with appetizing films)

    Time frame: 16 weeks after beginning of Olanzapine treatment

  2. Weight

    Time frame: 16 weeks after beginning of Olanzapine treatment

Secondary outcomes

  1. Fasting glucose

    Time frame: 16 weeks after beginning of Olanzapine treatment

  2. Insulin

    Time frame: 16 weeks after beginning of Olanzapine treatment

  3. Leptin

    Time frame: 16 weeks after beginning of Olanzapine treatment

  4. Ghrelin

    Time frame: 16 weeks after beginning of Olanzapine treatment

  5. Endogenous cannabinoids

    Time frame: 16 weeks after beginning of Olanzapine treatment

  6. Lipid profile

    Time frame: 16 weeks after beginning of Olanzapine treatment

  7. PANSS (Positive and negative syndrome scale)

    Time frame: 16 weeks after beginning of Olanzapine treatment

  8. CDSS (Calgary Depression scale for schizophrenia)

    Time frame: 16 weeks after beginning of Olanzapine treatment

  9. Three factors eating questionnaire

    Time frame: 16 weeks after beginning of Olanzapine treatment

  10. Fagerstrom test for nicotine dependence

    Time frame: 16 weeks after beginning of Olanzapine treatment

  11. Adult ADHD (attention deficit hyperactivity disorder) self report scale

    Time frame: 16 weeks after beginning of Olanzapine treatment

  12. Age

    Time frame: 16 weeks after beginning of Olanzapine treatment

  13. Sexe

    Time frame: 16 weeks after beginning of Olanzapine treatment

  14. Weight

    Time frame: 16 weeks after beginning of Olanzapine treatment

  15. Abdominal circumference

    Time frame: 16 weeks after beginning of Olanzapine treatment

  16. Number and times of hospitalization

    Time frame: 16 weeks after beginning of Olanzapine treatment

  17. Blood pressure

    Time frame: 16 weeks after beginning of Olanzapine treatment

  18. Prolactin

    Time frame: 16 weeks after beginning of Olanzapine treatment

  19. Onset of disease

    Time frame: 16 weeks after beginning of Olanzapine treatment

  20. Level of education

    Time frame: 16 weeks after beginning of Olanzapine treatment

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2006
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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