Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects

NCT00734435 | Terminated Phase 2

• 1 other identifier: OZ-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

schizophrenia; schizophreniform; schizoaffective disorder; Zyprexa; olanzapine

Outcome Measures

Primary Outcomes (1)

• Percentage change in total body weight

  Baseline to Week 16

Study Arms (2)

1

ACTIVE COMPARATOR

Zonisamide SR 360 mg and olanzapine 10-20 mg daily

Drug: zonisamide SR plus olanzapine

2

PLACEBO COMPARATOR

Placebo and olanzapine 10-20 mg daily

Drug: Placebo plus olanzapine

Interventions

zonisamide SR plus olanzapine DRUG

zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)

Also known as: Zyprexa

1

Placebo plus olanzapine DRUG

Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)

Also known as: Zyprexa

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orexigen Therapeutics, Inc: lead

Study Sites (9)

Synergy Research

National City, California, 91950, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

CNRI San Diego

San Diego, California, 92126, United States

Location

Florida Clincal Research Center

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center

Maitland, Florida, 34208, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

American Medical Research

Oak Brook, Illinois, 60523, United States

Location

Larue D. Carter Hospital

Indianapolis, Indiana, 46222, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11223, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

US (9)