Weight Gain Management in Patients With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00486005

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine Hydrochloride Drug: Nizatidine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Nizatidine Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	74
Study Start Date:	February 2003
Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486005

Locations

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, Brazil

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00486005 History of Changes
Other Study ID Numbers:	7932, F1D-BL-HGLA
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Schizophrenia
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Nizatidine
Olanzapine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists

Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012