Weight Gain Management in Patients With Schizophrenia

Lilly

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Nizatidine

Drug: Olanzapine Hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00486005

7932

F1D-BL-HGLA

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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