Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT00734435
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00734435
Study Brief:
Protocol Section:
NCT00734435