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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT00595504
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
* male or female, age 18-65 years
* treatment with clozapine, olanzapine, quetiapine or risperidone
* well established compliance with medications
* Body Mass Index (BMI) of \> 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of \> 30 Kg/m²:
Exclusion Criteria:
* inability to provide informed consent
* substance and alcohol abuse
* significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease
* current history of diabetes mellitus or thyroid disease
* women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* psychiatrically unstable, patients with major depression
* patients treated with medications known to affect glucose tolerance such as birth control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce weight loss will be excluded from the study
* treatment with fluvoxamine in the or ketoconazole past two weeks
* treatment with fluconazole (a strong CYP2C9 inhibitor).
* subjects treated with ziprasidone and aripiprazole conventional agents
* treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone, zaleplon. The use of stable daily doses of benzodiazepines is allowed.
* known hypersensitivity to ramelteon or any of its components
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00595504
Study Brief:
Protocol Section:
NCT00595504