Investigation of longlasting inhibition of the serotonin transporter in the human brain using functional imaging (fMRI)

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00028110
• Lead Sponsor: Bundesinstitut für Arzneimittel und Medizinprodukte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-31
• Study Start: 2022-02-14
• Results First Posted: 2024-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Written informed consent for the study
- Age restriction: 18-50 years
- Healthy to mildly impaired general health (ASA-Physical Status Classification (ASA 1-2), Haynes et Lawler 1995).
- BMI above 18 kg/m2
- Diagnosis of an affective disorder (Hamilton > 8) and new prescription of oral antidepressant therapy with an SSRI (for patients)
- No prescription of an SSRI within 9 months before the start of the study
- No prescription of any other antidepressant agent within 9 months before the start of the study (also includes opripamol, pregabalin, and St. John's wort preparations).

Exclusion Criteria

- For women: Pregnancy or lactation period
- Severe other acute or chronic illness, reduced general health ASA-Physical Status Classification (ASA 3-6)
- Substance-related addictive disorders
- Psychoses
- Metal implants in the body (e.g. pacemaker, copper coil in women)
- Wearing metallic (magnetic) and non-removable jewelry, tattoos, or cosmetics
- Strong fear of confined spaces (claustrophobia)
- Insufficient command of the German language for the processing of questionnaires
- Regular intake of other medications (except L-thyroxine, oral contraceptives, statins, ACE inhibitors)
- Regular intake of anticoagulant drugs, especially phenprocoumon (Marcumar), and of NSAIDs (especially acetylsalicylic acid) 2 weeks before the start of the study
- Existing suicidality

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Imaging of autoreceptor adaptation with inhibition of nucleus raphe activity in fMRI.

Secondary Outcome Measures

Name	Time	Method
- Alteration of neural correlates in endophenotypes of affective and serotonergic function (reactivity to emotional stimuli of high salience, reactivity to appetitive stimuli, reactivity to representations of separation and grief, propensity to or avoidance of negative cognitions, and cognitive inhibition processes) upon SSRI blockade.<br>- Validation of biological markers of serotonin transporter inhibition (genomics, pharmacological markers, blood clotting) in SSRI blockade and variability in the population.<br>- Comparison of neural correlates in the above endophenotypes of affective and serotonergic function between patients before therapy and in healthy control subjects.