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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05551468
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria at entry of the study:
* Age 13-21 years
* Adolescents who do NOT meet criteria of a current anxiety disorder (separation -, social - or generalized anxiety disorder, specific phobia, panic disorder, agoraphobia) or depressive disorder (major depressive -, persistent depressive -, or disruptive mood dysregulation disorder) based on a semi-structured diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5)), but DO meet the criteria for at least one PREVIOUS episode of one or the combination of the above mentioned disorders
Exclusion Criteria:
* A potential subject who currently meets criteria of any of the following mental health problems will be excluded from participation in this study:
* Alcohol or drug misuse
* Previous hypomania and/or mania
* Bipolar disorder
* Previous and/or current psychotic episode
Other exclusion criteria include:
* Only in remission of another anxiety or mood disorder than mentioned above at the inclusion criteria, namely premenstrual dysphoric disorder, depressive disorder due to another medical condition, substance/medication-induced depressive disorder, other specified depressive disorder, unspecified depressive disorder, selective mutism, substance/medication-induced anxiety disorder or anxiety disorder due to another medical condition, other specified anxiety disorder, unspecified anxiety disorder
* only in remission of PTSD or OCD
* ongoing current treatment (more than twice a month) for a mental health disorder including those listed under the inclusion criteria
* no or insufficient mastery of the Dutch language.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
21 Years
Study:
NCT05551468
Study Brief:
Protocol Section:
NCT05551468