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

Orexigen

Status and phase: Terminated; Phase 2

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: zonisamide SR plus olanzapine; Drug: Placebo plus olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734435

OZ-101

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Zonisamide SR 360 mg and olanzapine 10-20 mg daily

Treatment:

Drug: zonisamide SR plus olanzapine

2

Placebo Comparator group

Description:

Placebo and olanzapine 10-20 mg daily

Treatment:

Drug: Placebo plus olanzapine