A Randomized add-on Trial of D-serine for Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Depression Severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Depression Severity
Time Frame: Change from baseline HAM-D score at 6 weeks
measured with the Hamilton Depression Rating Scale (HAM-D)
Secondary Outcomes
- Inflammation(Change from baseline interleukin 1 and 6 level at 6 weeks)
- Anxiety(Change from baseline STAI score at 6 weeks)
- Prefrontal glutamate concentration(Change from baseline glutamate level at 6 weeks)
- Stress level(Change from baseline cortisol level at 6 weeks)
- Neurocognition(Change from baseline VLMT score at 6 weeks)
- Anhedonia(Change from baseline SHAPS score at 6 weeks)
Investigators
André Schmidt
Principal Investigator
Psychiatric Hospital of the University of Basel