D-serine Supplementation for Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT04721249
• Lead Sponsor: André Schmidt

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-07-01
• Primary Completion: 2023-10-30
• Study Completion: 2024-01-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Severity	Change from baseline HAM-D score at 6 weeks	measured with the Hamilton Depression Rating Scale (HAM-D)

Secondary Outcome Measures

Name	Time	Method
Anxiety	Change from baseline STAI score at 6 weeks	measured with the State-and Trait-Anxiety Inventory (STAI)
Inflammation	Change from baseline interleukin 1 and 6 level at 6 weeks	measured with the blood levels of interleukin 1 and 6
Prefrontal glutamate concentration	Change from baseline glutamate level at 6 weeks	measured with magnetic resonance spectroscopy (MRS)
Stress level	Change from baseline cortisol level at 6 weeks	measured with Cortisol awakening responses
Neurocognition	Change from baseline VLMT score at 6 weeks	measured with the Verbal Learning and Memory Test (VLMT)
Anhedonia	Change from baseline SHAPS score at 6 weeks	measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)

Trial Locations

Locations (1)

University of Basel, Department of Psychiatry (UPK); 🇨🇭 Basel, Baselstadt, Switzerland