NCT04721249Completed
D-serine Supplementation for Depression
A Randomized add-on Trial of D-serine for Depression
Source: ClinicalTrials.gov · Last updated 10 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 15 Jan 2021
- Start date
- 1 Jul 2021
- Primary completion date
- 30 Oct 2023
- Lead sponsor
- André Schmidt
- Diseases
- Depression
- NCT number
- NCT04721249
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 1 Jul 2021 to the primary completion date, 30 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other primary psychiatric diagnoses than MDD such as substance use and psychotic disorders
- Contradiction for MRI (no pacemaker, MRI incompatible metal implants or splinters in the body, past heart/head surgery, past stroke/brain injury, claustrophobia)
Other
- Serious suicide attempts
- Pregnant or lactating women (pregnancy test)
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Basel, Department of Psychiatry (UPK) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.