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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06805266
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of PD according to published criteria
2. Occurrence of depression according to Beck Depression Inventory II (score ≥ 15)
3. A score ≥ 2 on the freezing question #2.13 of part 2 of the MDS-UPDRS (moderate-severe FOG).
4. FOG not responsive to dopaminergic treatment.
Exclusion Criteria:
1. Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)
2. Concomitant treatment with other antidepressant drugs
3. Hepatic and renal insufficiency
4. Treatment with tramadol or triptans
5. Psychotic disorder
6. Dementia according to DSM-V
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06805266
Study Brief:
Protocol Section:
NCT06805266