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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03818256
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of schizophrenia or bipolar disorder
* Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
* Must be on a stable dose of medication for 1 month prior to Screening
* Are able to successfully complete placebo tablet swallow test
* Have a BMI ≥30 kg/m\^2.
Exclusion Criteria:
* Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)
* Have poorly controlled diabetes mellitus
* Have poorly controlled hypertension
* Have a history of symptomatic hypotension
* Have a history of orthostatic hypotension.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03818256
Study Brief:
Protocol Section:
NCT03818256