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A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode.

Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized.

The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment.

Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity.

This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all patients undergo the psychoeducational programme. The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI.

Condition Intervention Phase
Weight Gain
Drug: olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective/Parallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To observe the efficacy of a psychoeducational programme in managing the olanzapine-associated weight gain

Secondary Outcome Measures:
  • To study the physical and chemical changes induced by weight gain

Estimated Enrollment: 60
Study Start Date: March 2003
Estimated Study Completion Date: August 2005

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of BMI >7% (assessed during the routine visits from the beginning of antipsychotic treatment).
  • Male or female subjects at least 18 and no more than 65 years of age.
  • Subjects must be considered reliable.
  • Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol.
  • Each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document.

Exclusion criteria:

  • Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count <500 mm3).
  • Prior treatment with any antipsychotic drugs associated to olanzapine.
  • Judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00191828

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speack with your personal physician.
Sesto Fiorentino, Florence, Italy
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information Identifier: NCT00191828     History of Changes
Other Study ID Numbers: 7399
Study First Received: September 12, 2005
Last Updated: January 24, 2007

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on April 27, 2017