Weight Gain Management in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00486005
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 11, 2007
June 11, 2007
February 2003
Not Provided
Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain
Same as current
No Changes Posted
  • Compare the effect of olanzapine with nizatidine or placebo evaluated by the average alteration between the groups in cognitive control of appetite, disinhibition and susceptibility to hunger, variation of weight and total punctuation in BPRS
  • Compare the security of the association of olanzapine with nizatidine and olanzapine and placebo in relation to laboratory values, vital signs, and incidence of extrapyramidal symptoms
Same as current
Not Provided
Not Provided
 
Weight Gain Management in Patients With Schizophrenia
Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine

Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: Olanzapine Hydrochloride
  • Drug: Nizatidine
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
October 2003
Not Provided

Inclusion Criteria:

  • Patients, men or women, with age of 18 to 65 years
  • Patients must have schizophrenia that meets disease diagnostic criteria as defined in DSM-IV Sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator
  • Patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine.
  • The individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent
  • Women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.

Exclusion Criteria:

  • Participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (Visit 1)
  • People who have used clozapine within a period of 12 months before the beginning of the study
  • People with diagnosis of diabetes mellitus types I or II without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months
  • DSM-IV substance (except nicotine and caffeine) dependence within the past 30 days
  • Current participation in programs of weight loss
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00486005
7932, F1D-BL-HGLA
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP