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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191828
• Other study ID #: 7399
• Secondary ID: F1D-IT-HGLE
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: March 2003
• Est. completion date: August 2005

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Gain

Intervention

Drug:
• olanzapine

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observe the efficacy of a psychoeducational programme in managing the olanzapine-associated weight gain
Secondary	To study the physical and chemical changes induced by weight gain