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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05951660
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* A diagnosis in the schizophrenic spectrum (ICD10 F2x)
* One of the following:
1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring
3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2
* Ongoing treatment with at least one antipsychotic agent
* A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Exclusion Criteria:
* Incapacitated or subject to mental health probation
* Unable to speak danish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05951660
Study Brief:
Protocol Section:
NCT05951660