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A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain

NCT00363376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-04-13

No results posted yet for this study

Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipolar disorders.

Conditions

  • Weight Gain

Interventions

DRUG

zonisamide

Zonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea).

DRUG

olanzapine

olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects

DRUG

Zonisamide

zonisamide ranging from 100mg to 600mg daily

DRUG

Sugar Pill (placebo)

sugar pill (placebo) for zonisamide

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of Cincinnati

    collaborator OTHER

  • Lindner Center of HOPE

    lead OTHER

Principal Investigators

  • Susan McElroy, MD · The Lindner Center of HOPE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363376 on ClinicalTrials.gov