An interventional study of D-serine and Placebo in Major Depressive Disorder, sponsored by André Schmidt. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by André Schmidt · Not applicable, Interventional, and Treatment
The glutamate system is emerging as target for the development of novel antidepressant medication, in particular compounds modulating the NMDA receptor. While the NMDA receptor antagonist ketamine is an effective option for many treatment-restistant patients, it is also accompanied by dissociative and cognitive effects and also bears the risk to develop addiction, side effects that are significantly restricting its clinical utility. There is now compelling evidence of the antidepressant potential of D-serine, a NMDAR co-agonist. Compared to ketamine, D-serine goes along without any psychotomimetic effects or other side effects and thus might be a prom-ising novel antidepressant.
This study represents the first randomized control trial to test the efficacy of D-serine as an adjuvant therapy in patients with depression and thereby adds to re-cent efforts to establish novel glutamatergic antidepressants. Besides clinical measures, this study also explores the biological mechanisms underlying D-serine's clinical effect.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 44 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →This is the only study on the registry with André Schmidt as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: D-serine
Dietary Supplement: Placebo
Patients will receive four 500mg capsules of D-serine each day over a course of six weeks (two after breakfast and two after dinner).
Patients in the placebo group will receive four placebo capsules each day (two after breakfast and two after dinner). The placebo capsules will contain Mannotol / Mannitol-Silica (99.5/0.5, respectively) and will be indistinguishable from D-serine by matching colour, shape, size and packaging.
Depression Severity
measured with the Hamilton Depression Rating Scale (HAM-D)
Time frame: Change from baseline HAM-D score at 6 weeks
Anxiety
measured with the State-and Trait-Anxiety Inventory (STAI)
Time frame: Change from baseline STAI score at 6 weeks
Anhedonia
measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)
Time frame: Change from baseline SHAPS score at 6 weeks
Neurocognition
measured with the Verbal Learning and Memory Test (VLMT)
Time frame: Change from baseline VLMT score at 6 weeks
Prefrontal glutamate concentration
measured with magnetic resonance spectroscopy (MRS)
Time frame: Change from baseline glutamate level at 6 weeks
Stress level
measured with Cortisol awakening responses
Time frame: Change from baseline cortisol level at 6 weeks
Inflammation
measured with the blood levels of interleukin 1 and 6
Time frame: Change from baseline interleukin 1 and 6 level at 6 weeks
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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