Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
This study has been terminated.
(Sponsor Decision- Financial Considerations)
Sponsor:
Orexigen Therapeutics, Inc
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00734435
First received: August 12, 2008
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: zonisamide SR plus olanzapine Drug: Placebo plus olanzapine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Orexigen Therapeutics, Inc:
Primary Outcome Measures:
- Percentage change in total body weight [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Zonisamide SR 360 mg and olanzapine 10-20 mg daily
|
Drug: zonisamide SR plus olanzapine
zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
Other Name: Zyprexa
|
|
Placebo Comparator: 2
Placebo and olanzapine 10-20 mg daily
|
Drug: Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
Other Name: Zyprexa
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734435
Locations
| United States, California | |
| Synergy Research | |
| National City, California, United States, 91950 | |
| UCI Medical Center | |
| Orange, California, United States, 92868 | |
| CNRI San Diego | |
| San Diego, California, United States, 92126 | |
| United States, Florida | |
| Florida Clincal Research Center | |
| Bradenton, Florida, United States, 34208 | |
| Florida Clinical Research Center | |
| Maitland, Florida, United States, 34208 | |
| United States, Georgia | |
| Atlanta Center for Medical Research | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| American Medical Research | |
| Oak Brook, Illinois, United States, 60523 | |
| United States, Indiana | |
| Larue D. Carter Hospital | |
| Indianapolis, Indiana, United States, 46222 | |
| United States, New York | |
| Brooklyn Medical Institute | |
| Brooklyn, New York, United States, 11223 | |
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
| Principal Investigator: | Alan Breier, MD | Larue D. Carter Hospital |
| Principal Investigator: | Mohammed Alam, MD | American Medical Research |
| Principal Investigator: | Gerald Maguire, MD | UCI Medical Center |
| Principal Investigator: | Zinoviy Benzar, MD | Brooklyn Medical Institute |
| Principal Investigator: | Mohammed Bari, MD | Synergy Research |
| Principal Investigator: | Tran Johnson, MD | CNRI |
| Principal Investigator: | Eduard Gfeller, MD | Florida Clinical Research Center, Maitland Florida |
| Principal Investigator: | Andrew Cutler, MD | Florida Clinical Research Center, Bradenton Florida |
| Principal Investigator: | Robert Riesenberg, MD | Atlanta Center for Medical Research |
More Information
No publications provided
| Responsible Party: | Orexigen Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00734435 History of Changes |
| Other Study ID Numbers: | OZ-101 |
| Study First Received: | August 12, 2008 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Orexigen Therapeutics, Inc:
|
schizophrenia schizophreniform schizoaffective disorder Zyprexa olanzapine |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Weight Gain Schizophrenia and Disorders with Psychotic Features Mental Disorders Body Weight Changes Body Weight Signs and Symptoms Zonisamide Olanzapine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013