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D-serine Supplementation for Depression

NCT04721249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

Interventions

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).

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • André Schmidt

    lead OTHER

Principal Investigators

  • André Schmidt, PD Dr · University of Basel, Department of Psychiatry (UPK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-10-30
Completion
2024-01-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721249 on ClinicalTrials.gov