Weight Gain Management in Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Olanzapine Hydrochloride (Drug); Nizatidine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

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, Brazil

Lilly Clinical Trial Registry

Starting date: February 2003
Ending date: October 2003
Last updated: June 11, 2007