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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT01822418
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 60 years.
2. Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
3. Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
4. Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
5. Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
6. The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient's participation.
Exclusion Criteria:
1. Contraindications against AGO treatment
2. Insufficient contraception in women of childbearing potential when sexually active.
3. Gravidity or breastfeeding.
4. Addiction to alcohol
5. Current abuse of THC and other illegal substances according to ICD-10
6. Dementia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01822418
Study Brief:
Protocol Section:
NCT01822418