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Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft and are the current first line of pharmacological antidepressive treatment. Yet, there is a missing link between this first molecular step in their mechanism of action and observed clinical improvement. We have determined to establish a framework combining genuine molecular and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system in order to predict antidepressant treatment response.
Objectives:
Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.
Materials and methods:
40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT occupancy with drug challenge, applied after 70min, in a single session. Scanning will be terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment with repeated evaluation of response for 3 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MR [11C]DASB | Diagnostic Test | 2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over) |
| |
| Citalopram | Drug | 8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design |
| |
| Escitalopram (Mirtazapine/Duloxetine/Venlafaxine) | Drug | After completion of imaging procedures, patients will receive treatment with escitalopram 10-20mg. In case of non-response, after 6 weeks, treatment will be switched to either Mirtazapine, Duloxetine or Venlafaxine |
| |
| Placebo | Drug | 8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HDRS) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550277 | Derived | Zadka L, Eggerstorfer B, Buzalewicz I, Vraka C, Rusak A, Godbersen GM, Opalinska A, Unterholzner J, Ulatowska-Jarza A, Philippe C, Haczkiewicz-Lesniak K, Silberbauer LR, Murgas M, Nics L, Hahn A, Hacker M, Gomulkiewicz A, Rujescu D, Podhorska-Okolow M, Lanzenberger R, Gryglewski G. Phenotyping extracellular vesicles and their serotonin transporter cargo in major depressive disorder. J Affect Disord. 2025 Nov 15;389:119740. doi: 10.1016/j.jad.2025.119740. Epub 2025 Jun 21. | |
| 33667309 |
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| Derived |
| Seiger R, Gryglewski G, Klobl M, Kautzky A, Godbersen GM, Rischka L, Vanicek T, Hienert M, Unterholzner J, Silberbauer LR, Michenthaler P, Handschuh P, Hahn A, Kasper S, Lanzenberger R. The Influence of Acute SSRI Administration on White Matter Microstructure in Patients Suffering From Major Depressive Disorder and Healthy Controls. Int J Neuropsychopharmacol. 2021 Jul 23;24(7):542-550. doi: 10.1093/ijnp/pyab008. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064847 | Multimodal Imaging |
| D057054 | Molecular Imaging |
| D015283 | Citalopram |
| D000089983 | Escitalopram |
| D000078785 | Mirtazapine |
| D003909 | Dexetimide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D015336 | Molecular Probe Techniques |
| D008919 | Investigative Techniques |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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