A Phase 4 interventional study of WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline and Cipralex (escitalopram) in Major Depressive Disorder (MDD), sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment
Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation. Thus, it is assumed that the synthesis of dopamine in the brain of depressed individuals could be impaired. The specific effect of common antidepressants on the human reward system in depression has not yet been sufficiently investigated. In particular, it is unclear whether depressed patients exhibit reward-specific changes of dopamine synthesis, and whether or not these changes can be differentially affected by diverse types of antidepressants. Neurotransmitter systems can be visualized in the brain using positron emission tomography (PET). Additionally, brain structure and function can be studied using magnetic resonance imaging (MRI). For the visualization of dopamine synthesis in the brain, the radioligand [18F]FDOPA can be used in PET measurements. To assess task-relevant changes of diverse radioligands and thus specific metabolic processes in the brain during specific tasks, a recently developed PET-approach can be used which has already been successfully applied in a pilot study with healthy volunteers. In the present project, 60 depressed subjects and 30 healthy controls will undergo PET/MR-imaging twice. Depressed subjects will be assigned to 1 of 2 treatment groups. 30 depressive subjects will receive bupropion, the other 30 patients will be treated with escitalopram. After a treatment period of 6 weeks, the 2nd PET measurement will be performed in all participants, aiming to detect potential reward-specific changes of dopamine synthesis. The investigators hypothesize that reward-specific changes of dopamine synthesis will be lower in depressed subjects than in healthy controls, that reward-specific changes of dopamine synthesis will be significantly higher in the bupropion group than in the escitalopram group, and that the changes of dopamine synthesis will be associated with functional changes in the brain (measured by simultaneous functional MRI scans). This will be the first study comparing the effects of escitalopram and bupropion on task-specific dopamine synthesis and thus on the human reward system. The study is expected to yield new insights for individual treatment concepts in the therapy of depression.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
Bupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline
Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
Drug: Cipralex (escitalopram)
Healthy controls will only attend imaging procedures without medication intake
Bupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
Changes of the reward specific dopamine synthesis rate in the nucleus accumbens of depressed individuals after 6-8 weeks of antidepressant intake assessed via functional PET
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using \[18F\]FDOPA as an index of the dopamine synthesis rate
Time frame: 6-8 weeks
Relationship between potential changes of the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET and treatment response in depressed individuals after 6-8 weeks of antidepressant intake
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using \[18F\]FDOPA as an index of the dopamine synthesis rate; Treatment response rates will be assessed at baseline and after 6-8 weeks of antidepressant therapy via the Hamilton Depression Rating Scale with 29 items (HDRS29) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame: 6-8 weeks
Difference in changes to the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET in depressed patients taking bupropion vs. escitalopram after 6-8 weeks of therapy
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using \[18F\]FDOPA as an index of the dopamine synthesis rate
Time frame: 6-8 weeks
Relationship between the reward-specific dopamine synthesis rate (assessed via functional PET) and fMRI activation across healthy volunteers and depressed patients, both at baseline and after 6-8 weeks of therapy
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using \[18F\]FDOPA as an index of the dopamine synthesis rate; fMRI activation: Blood-Oxygenation-Level Dependent Signal via functional Magnetic Resonance Imaging
Time frame: 6-8 weeks
Remission rates in depressed patients being treated with either escitalopram or bupropion in a longitudinal design
Remission rates will be assessed at baseline and after 6-8 weeks of antidepressant therapy via the Hamilton Depression Rating Scale with 29 items (HDRS29) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame: 6-8 weeks
Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers via functional PET
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using \[18F\]FDOPA as an index of the dopamine synthesis rate; assessed at baseline and after 6-8 weeks without any interventions in between
Time frame: 6-8 weeks
Changes in cerebral GABA and Glutamate after antidepressant treatment measured by Magnetic Resonance Spectroscopy (MRS)
GABA+/tCr, GABA+/Glx, and Glx/tCr ratios will be assessed via MRS before and after antidepressant treatment over 6-8 weeks. This will be an optional measurement.
Time frame: 6-8 weeks
Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.
Of 74 non-industry phase 4 interventional studies under Depressive Disorder, Major, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 48 months is above that.
Counting every sponsor, half of 93 studies reached it within 34 months; a quarter within 19 and three quarters within 58.
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Studies of the drug tested here: Escitalopram
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