Overview

A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lindner Center of HOPE
Collaborators:
Eli Lilly and Company
University of Cincinnati
Treatments:
Olanzapine
Zonisamide
Criteria
Inclusion Criteria:

Criteria for entering this study will include all of the following:

1. Subjects must be 18 years of age or older.

2. Subjects must have schizophrenia, schizoaffective disorder, schizophreniform disorder,
delusional disorder, psychotic disorder NOS, or bipolar I, II, or NOS disorder as
defined by DSM-IV-TR criteria.

3. Subjects must have a BMI > 22.

4. Subjects must sign the Informed Consent Document after the nature of the trial has
been fully explained.

5. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or
practicing medically acceptable effective method(s) of contraception (e.g., hormonal
methods, intrauterine device) for at least one month prior to study entry and
throughout the study.

6. If exposed to olanzapine in the past, subjects must be free of olanzapine for > 3
months prior to randomization to study medication.

Exclusion Criteria:

Criteria for exclusion from this study will be any of the following:

1. Subjects with clinically significant suicidal or homicidal ideation.

2. Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or
other cognitive disorders; a psychotic or mood disorder secondary to substance use or
a general medical disorder; or a DSM-IV diagnosis of a substance use disorder within
the past six months.

3. Cardiovascular, endocrine, neurologic, or hematologic disease as determined by the
clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism
unless stabilized on thyroid replacement > 3 months.

4. Subjects who are allergic to or who have demonstrated hypersensitivity to or
significant adverse event from olanzapine.

5. Subjects who are allergic to or who have demonstrated hypersensitivity to zonisamide.

6. Women who are pregnant or nursing.

7. Subjects who have received an experimental drug or used an experimental device within
30 days.