Weight Gain Management in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486005
• Other study ID #: 7932
• Secondary ID: F1D-BL-HGLA
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: February 2003
• Est. completion date: October 2003

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Weight Gain

Intervention

Drug:
• Olanzapine Hydrochloride

• Nizatidine

• Placebo

Locations

Country	Name	City	State
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain
Secondary	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
Secondary	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

External Links

•   Lilly Clinical Trial Registry