Status:
COMPLETED
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Lead Sponsor:
Eli Lilly and Company
Conditions:
Weight Gain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 weig...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00191828
Start Date
March 1 2003
End Date
August 1 2005
Last Update
January 26 2007
Active Locations (1)
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1
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