Status:
ACTIVE_NOT_RECRUITING
Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Philipps University Marburg
Helmut Schmidt University
Conditions:
Depressive Symptoms
Expectations
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Antidepressant medication is established as an evidence-based, guideline-recommended treatment for Major Depressive Disorders. In the past decades, prescriptions of antidepressant medication have mark...
Detailed Description
Antidepressant medication is established as an evidence-based, guideline-recommended treatment for Major Depressive Disorders. Following initial response to antidepressant medication and full remissio...
Eligibility Criteria
Inclusion
- Adult patients (18 to 75 years) with fully remitted Major Depressive Disorder, single or recurrent, as main diagnosis confirmed by prescribing physician and SCID-5 (American Psychiatric Association, 2013)
- Intake of SSRI/SNRI (citalopram: 20-40mg, escitalopram: 10-20mg, sertraline: 50-150mg, venlafaxine: 75-150mg, duloxetine: 60-100mg, paroxetine: 20-40mg) or NaSSA (mirtazapine: 30-45mg)
- Discontinuation wish by patient supported by prescribing physician
- Fulfils criteria of the German S3 national guideline recommendations for treatment of Major Depressive Disorders to discontinue antidepressant medication: a) response to antidepressant medication, b) symptom remission for at least four months (for a single episode) or two years (for two or more episodes with significant functional impairment) and c) concurrent intake of antidepressant medication (at least 4 weeks on a steady dose)
Exclusion
- Acute or chronic somatic illness and/or intake of medication which might interfere with depressive disorder, antidepressant medication or proposed study
- Acute suicidality, psychotic symptoms, substance abuse or addiction, current mania, or hypomania confirmed by SCID-5 (American Psychiatric Association, 2013) or other psychopathology which might interfere with depressive disorder, antidepressant medication or proposed study
- Any history of bipolar disorder or psychosis confirmed by SCID-5 (American Psychiatric Association, 2013)
- Severe stressful life events (e.g., death of a family member) within six months prior to study participation
- Insufficient German language proficiency
- No informed consent
- Upon optional participation: MRI-specific exclusion criteria (phobic anxiety, claustrophobia, ferromagnetic implants, etc.)
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05191277
Start Date
August 1 2022
End Date
November 26 2025
Last Update
April 23 2025
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251