Clinical trial NCT04721249: D-serine Supplementation for Depression
Official title: A Randomized add-on Trial of D-serine for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Psychiatric Hospital of the University of Basel
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-60
* Inpatients with a diagnosis of MDD with a current moderate-to-severe episode (HAM-D score \> 16) (7)
* Treatment as usual (TAU) for depression. TAU for depression may include no treatment at all or standard pharmacotherapy (antidepressants and antipsychotics such as aripiprazole, risperidone or quetiapine) and / or psychotherapy.
* Able to read and understand study procedures and participant's information

Exclusion Criteria:

* Other primary psychiatric diagnoses than MDD such as substance use and psychotic disorders
* Serious suicide attempts
* Contradiction for MRI (no pacemaker, MRI incompatible metal implants or splinters in the body, past heart/head surgery, past stroke/brain injury, claustrophobia)
* Pregnant or lactating women (pregnancy test)

Primary outcomes:
measure: Depression Severity
timeFrame: Change from baseline HAM-D score at 6 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline STAI score at 6 weeks
measure: Anhedonia
timeFrame: Change from baseline SHAPS score at 6 weeks
measure: Neurocognition
timeFrame: Change from baseline VLMT score at 6 weeks
measure: Prefrontal glutamate concentration
timeFrame: Change from baseline glutamate level at 6 weeks
measure: Stress level
timeFrame: Change from baseline cortisol level at 6 weeks
measure: Inflammation
timeFrame: Change from baseline interleukin 1 and 6 level at 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Department of Psychiatry (UPK)
state: Baselstadt
Study officials:
affiliation: University of Basel, Department of Psychiatry (UPK)
name: André Schmidt, PD Dr
role: PRINCIPAL_INVESTIGATOR
References: