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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT05051995
Eligibility Criteria:
Inclusion Criteria:
* Adult participants (18+years) with a former diagnoses of major depressive disorder (MDD), single or recurrent as main diagnosis confirmed by prescribing physician and currently remitted
* Intake of selective serotonin reuptake inhibitors (SSRI)/ serotonin-norepinephrine reuptake inhibitors (SNRI) (citalopram 20-40mg, duloxetine 60-100mg, escitalopram 10-20mg, paroxetine 20-40mg, sertraline 50-150mg, venlafaxine 75-150mg) or noradrenergic and specific serotonergic antidepressants (NaSSA) (mirtazapine 30-45mg)
* Discontinuation wish by patient supported by prescribing physician
* Fulfils the criteria of the S3 national guideline recommendations "Depression" to discontinue antidepressant medication: a) response to antidepressant; b) symptom remission for at least 4 months (first episode) or for 2 years (2 or more episodes with significant functional impairment), constant intake of antidepressant medication (at least 4 weeks on a steady dose)
* Informed consent
Exclusion Criteria:
* Current moderate or severe psychopathological symptoms or psycho-social impairments
* Acute or chronic somatic illness which might interfere with depressive disorder, antidepressant or proposed study
* Acute suicidality, psychotic symptoms, substance abuse, or addiction, current mania, or hypomania confirmed by SCID-5 or other psychopathology which might interfere with depressive disorder, antidepressant or proposed study
* Any history of bipolar disorder or psychosis confirmed by SCID-5
* Severe stressful life events (e.g., death of a family member) within six months prior to study participation
* Current pregnancy
* Insufficient German language proficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05051995
Study Brief:
Protocol Section:
NCT05051995