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Completed

NCT Number: NCT04721249

D-serine Supplementation for Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Department of Psychiatry (UPK)

Basel, Canton of Basel-City, 4002, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

D-serine

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Depression Severity

    Time frame: Change from baseline HAM-D score at 6 weeks

    measured with the Hamilton Depression Rating Scale (HAM-D)

Secondary outcomes

  1. Anxiety

    Time frame: Change from baseline STAI score at 6 weeks

    measured with the State-and Trait-Anxiety Inventory (STAI)

  2. Anhedonia

    Time frame: Change from baseline SHAPS score at 6 weeks

    measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)

  3. Neurocognition

    Time frame: Change from baseline VLMT score at 6 weeks

    measured with the Verbal Learning and Memory Test (VLMT)

  4. Prefrontal glutamate concentration

    Time frame: Change from baseline glutamate level at 6 weeks

    measured with magnetic resonance spectroscopy (MRS)

  5. Stress level

    Time frame: Change from baseline cortisol level at 6 weeks

    measured with Cortisol awakening responses

  6. Inflammation

    Time frame: Change from baseline interleukin 1 and 6 level at 6 weeks

    measured with the blood levels of interleukin 1 and 6

Sponsors and collaborators

Lead sponsor

André Schmidt

Other

Registry information

Official study title

A Randomized add-on Trial of D-serine for Depression

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 22, 2021
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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