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CompletedNCT00486005Updated Jun 13, 2007

Weight Gain Management in Patients With Schizophrenia

A Phase 4 interventional study of Olanzapine Hydrochloride and Nizatidine in Schizophrenia, sponsored by Eli Lilly and Company. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-06-13.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Schizophrenia
03

In context

Weight Gain

405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.

This study's enrollment of 74 is below the median of 83 across 324 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
74 participants (actual)

Interventions

  • DrugOlanzapine Hydrochloride
  • DrugNizatidine
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00486005
Lead sponsor
Eli Lilly and Company
First posted
Jun 13, 2007
Start date
Feb 2003
Completion
Oct 2003
Last update
Jun 13, 2007

Study contacts

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 · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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