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Weight Gain Management in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00486005
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Hydrochloride Drug: Nizatidine Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine
Study Start Date : February 2003
Actual Study Completion Date : October 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486005


Locations
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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
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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
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00486005    
Other Study ID Numbers: 7932
F1D-BL-HGLA
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Weight Gain
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Olanzapine
Nizatidine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Anti-Ulcer Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents