D-serine Supplementation for Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721249
• Other study ID #: AS-2124
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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