Overview

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

Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Orexigen Therapeutics, Inc
Treatments:
Olanzapine
Zonisamide
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