Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
Information source: Orexigen Therapeutics, Inc
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
Intervention: zonisamide SR plus olanzapine (Drug); Placebo plus olanzapine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Orexigen Therapeutics, Inc Official(s) and/or principal investigator(s):
Alan Breier, MD, Principal Investigator, Affiliation: Larue D. Carter Hospital
Mohammed Alam, MD, Principal Investigator, Affiliation: American Medical Research
Gerald Maguire, MD, Principal Investigator, Affiliation: UCI Medical Center
Zinoviy Benzar, MD, Principal Investigator, Affiliation: Brooklyn Medical Institute
Mohammed Bari, MD, Principal Investigator, Affiliation: Synergy Research
Tran Johnson, MD, Principal Investigator, Affiliation: CNRI
Eduard Gfeller, MD, Principal Investigator, Affiliation: Florida Clinical Research Center, Maitland Florida
Andrew Cutler, MD, Principal Investigator, Affiliation: Florida Clinical Research Center, Bradenton Florida
Robert Riesenberg, MD, Principal Investigator, Affiliation: Atlanta Center for Medical Research
Summary
The purpose of this study is to determine if zonisamide SR will prevent weight gain in
schizophrenic subjects who take olanzapine (Zyprexa)
Clinical Details
Official title: A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage change in total body weight
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female subjects,18-55 years of age
- Outpatients diagnosed with schizophrenia, schizoaffective disorder, or
schizophreniform disorder
- Body mass index (BMI) between 22-35 kg/m2 (inclusive)
- Negative serum pregnancy test in women of child-bearing potential
- If women of child-bearing potential, must be non-lactating and agree to use an
acceptable form of contraception, which in all cases, includes one type of barrier
method, throughout the study period and for 30 days after discontinuation of study
drug
- Subject requires a change in antipsychotic treatment and olanzapine is deemed by the
Investigator to be a reasonable antipsychotic treatment choice
- No clinically significant abnormality on ECG
- No clinically significant laboratory abnormality
- Negative urine drug screen
- Must be considered reliable and possess a level of understanding that enables the
subject to provide written informed consent and to comply with protocol procedures and
schedule
- Must be able to read and understand English
Exclusion Criteria:
- Diagnosis of substance dependence within the 6 months prior to randomization
- diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months
prior to randomization
- Suicidal behavior or ideation within 3 months prior to randomization, or any current
suicidal ideation or intent
- Presence of dementia or other organic brain syndrome
- Serious or unstable medical illnesses
- Known, uncorrected narrow-angle glaucoma
- Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to
randomization
- Require treatment with any typical or atypical antipsychotic in addition to
olanzapine
Locations and Contacts
Synergy Research, National City, California 91950, United States; Recruiting
Shawna Blackmun, Phone: 888-619-7572, Email: blackmuns@synergysandiego.com
Mohammed Bari, MD, Principal Investigator
CNRI San Diego, San Diego, California 92126, United States; Recruiting
Tran Johnson, MD, Phone: 858-566-8222, Email: CNRI@pacbell.net
Tran Johnson, MD, Principal Investigator
UCI Medical Center, Orange, California 92868, United States; Not yet recruiting
Inee Byun, Phone: 714-456-3489, Email: ibyun@uci.edu
Gerald Maguire, MD, Principal Investigator
Florida Clinical Research Center, Maitland, Florida 34208, United States; Recruiting
Theresa Harden, Phone: 941-782-4628, Email: tharden@flcrc.com
Eduard Gfeller, MD, Principal Investigator
Florida Clincal Research Center, Bradenton, Florida 34208, United States; Recruiting
Gilbert De la Cruz, Phone: 407-644-1165, Email: gdelacruz@coreresearch.com
Andrew Cutler, MD, Principal Investigator
Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States; Recruiting
Kelly Calistri, Phone: 404-881-5800, Email: kcalistri@acmr.org
Robert Riesenberg, MD, Principal Investigator
American Medical Research, Oak Brook, Illinois 60523, United States; Recruiting
Linda Zusevics, Phone: 630-928-1000, Email: lindaz@americanmedicalresearch.com
Mohammed Alam, MD, Principal Investigator
Larue D. Carter Hospital, Indianapolis, Indiana 46222, United States; Recruiting
Amy Frazer, Phone: 317-941-4275, Email: aefrazer@iupui.edu
Alan Breier, MD, Principal Investigator
Brooklyn Medical Institute, Brooklyn, New York 11223, United States; Recruiting
Polina Sadkovets, Phone: 718-456-3489, Email: psadkovets@gminstitutes.com
Zinoviy Benzar, MD, Principal Investigator
Additional Information
Starting date: August 2008
Ending date: August 2009
Last updated: October 30, 2008
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