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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04721249
Other study ID # AS-2124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date January 30, 2024

Study information

Verified date May 2024
Source Psychiatric Hospital of the University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Intervention

Dietary Supplement:
D-serine
Patients will receive four 500mg capsules of D-serine each day over a course of six weeks (two after breakfast and two after dinner).
Placebo
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.

Locations

Country Name City State
Switzerland University of Basel, Department of Psychiatry (UPK) Basel Baselstadt

Sponsors (1)

Lead Sponsor Collaborator
André Schmidt

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Severity measured with the Hamilton Depression Rating Scale (HAM-D) Change from baseline HAM-D score at 6 weeks
Secondary Anxiety measured with the State-and Trait-Anxiety Inventory (STAI) Change from baseline STAI score at 6 weeks
Secondary Anhedonia measured with the Snaith-Hamilton-Pleasure Scale (SHAPS) Change from baseline SHAPS score at 6 weeks
Secondary Neurocognition measured with the Verbal Learning and Memory Test (VLMT) Change from baseline VLMT score at 6 weeks
Secondary Prefrontal glutamate concentration measured with magnetic resonance spectroscopy (MRS) Change from baseline glutamate level at 6 weeks
Secondary Stress level measured with Cortisol awakening responses Change from baseline cortisol level at 6 weeks
Secondary Inflammation measured with the blood levels of interleukin 1 and 6 Change from baseline interleukin 1 and 6 level at 6 weeks
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