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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02306551
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women with Psychotic Disorder (DSM-5: Delusional Disorder (297.1)
* Schizophreniform Disorder (295.4), Schizophrenia (295.90), Schizoaffective Disorder (295.70)
* Brief Psychotic Disorder (298.8) Other specified schizophrenia spectrum and other psychotic disorder (298.8), Unspecified schizophrenia spectrum and other psychotic disorder (298.9) )
* Lifetime diagnosis of DSM-5 Bipolar I and II Disorder (296.89)
* Diagnosis of DSM-5 Major Depressive Disorder current single episode (current 296.22 - 296.25) or recurrent episode (296.32 - 296.35)
* Non-psychiatric control group defined as mothers without any history of treatment or admission for a psychiatric disorder or drug or alcohol addiction.
* Partners of participating women with an expected care-giving role in relation to the infant will also be eligible for participation in the study.
* Infants of participating pregnant women will be included from birth.
Exclusion Criteria:
* Unable to provide informed consent to participate
* Unable to speak English or Danish because of the requirement to complete assessments,
* Miscarriage.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02306551
Study Brief:
Protocol Section:
NCT02306551