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OpenTrials
Completed

NCT Number: NCT00169702

The Effect of a Weight Management Program During Treatment With Olanzapine

The study is a prospective, randomized, open-label study.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heinrich-Heine-University, Rhineland State Clinics Düsseldorf

Düsseldorf, Rhineland State, 40629, Germany

About this study

The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
  • Ages between 18 and 65
  • Informed consent
  • Weight gain of at least 1.5 kg in the first 4 weeks
  • A sufficient understanding to participate adequately in the weight management program
  • Patients must agree to cooperate with all tests and examinations required by the protocol.
  • Each patient must understand the nature of the study and must sign an informed consent document.

Exclusion criteria

  • Serious, unstable somatic illnesses
  • Illnesses associated with weight gain including renal and endocrine diseases
  • Weight change greater than 3 kg in the preceding three months
  • Weight gain less than 1.5 kg in the first 4 weeks

Treatment and study plan

Weight management program

Behavioral

12 sessions, psychoeducation

Primary outcomes

  1. difference in mean weight gain

    Time frame: November 2007

Secondary outcomes

  1. changes in waist circumference, blood pressure, blood lipids, fasting glucose

    Time frame: November 2007

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Eli Lilly and Company
  • Else Kröner Fresenius Foundation
  • Technical University of Munich

Registry information

Official study title

The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study

Important dates

Study start
2003
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jan 30, 2008

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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