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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03884933
Eligibility Criteria:
Inclusion Criteria:The target population for inclusion in the study are consenting adults (ages 18-65 years) with severe mental illness (SMI), defined based on Deslespaul's conceptualisation of SMI:
1. meets criteria for (and presence of) bipolar disorder, severe major depression, schizophrenia, schizophreniform, and schizoaffective disorder according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10). The person should require care and treatment and not be in symptomatic remission;
2. has severe limitations in social and community functioning;
3. problems are not transient in nature; the problems are systematic and long-term, and potentially chronic, intermitted, and/or recurrent;
4. coordinated care provided by care networks or multidisciplinary teams is needed to deliver treatment
5. Patients with prevalence of suicidal behaviours (including suicide attempts)
Exclusion criteria are:
1. Patients under the age of 18
2. Patients with dementia or Alzheimer's disease
3. Patients for whom treatment is legally prescribed (in forensic psychiatry), however if they are discharged from the forensic ward, and still in need of treatment they can be included
Healthy Volunteers:
False
Study:
NCT03884933
Study Brief:
Protocol Section:
NCT03884933