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:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00202293
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 15 to 29.
* Experiencing a first episode psychosis.
* Meet DSM-IV criteria for bipolar either manic or mixed episode, or schizoaffective disorder manic episode.
* Minimum score of 20 on the YMRS
* Written informed consent to participation.
Exclusion Criteria:
* Patients at immediate risk of committing harm to self or others
* Use of neuroleptics or mood-stabilisers in the two months preceding admission to EPPIC
* Organic mental disease, including mental retardation
* History of clinically significant illness (liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances).
* Clinically relevant biochemical or hematological abnormalities.
* Pregnant or lactating woman
* History of epilepsy
* History of severe drug allergy or hypersensitivity
* Non fluency in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
29 Years
Study:
NCT00202293
Study Brief:
Protocol Section:
NCT00202293