Back to resultsD-serine Supplementation for Depression
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
D-serine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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)
Sites / Locations
- University of Basel, Department of Psychiatry (UPK)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Verum
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Depression Severity
measured with the Hamilton Depression Rating Scale (HAM-D)
Secondary Outcome Measures
Anxiety
measured with the State-and Trait-Anxiety Inventory (STAI)
Anhedonia
measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)
Neurocognition
measured with the Verbal Learning and Memory Test (VLMT)
Prefrontal glutamate concentration
measured with magnetic resonance spectroscopy (MRS)
Stress level
measured with Cortisol awakening responses
Inflammation
measured with the blood levels of interleukin 1 and 6
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04721249
Brief Title
D-serine Supplementation for Depression
Official Title
A Randomized add-on Trial of D-serine for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
André Schmidt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
D-serine
Intervention Description
Patients will receive four 500mg capsules of D-serine each day over a course of six weeks (two after breakfast and two after dinner).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Depression Severity
Description
measured with the Hamilton Depression Rating Scale (HAM-D)
Time Frame
Change from baseline HAM-D score at 6 weeks
Secondary Outcome Measure Information:
Title
Anxiety
Description
measured with the State-and Trait-Anxiety Inventory (STAI)
Time Frame
Change from baseline STAI score at 6 weeks
Title
Anhedonia
Description
measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)
Time Frame
Change from baseline SHAPS score at 6 weeks
Title
Neurocognition
Description
measured with the Verbal Learning and Memory Test (VLMT)
Time Frame
Change from baseline VLMT score at 6 weeks
Title
Prefrontal glutamate concentration
Description
measured with magnetic resonance spectroscopy (MRS)
Time Frame
Change from baseline glutamate level at 6 weeks
Title
Stress level
Description
measured with Cortisol awakening responses
Time Frame
Change from baseline cortisol level at 6 weeks
Title
Inflammation
Description
measured with the blood levels of interleukin 1 and 6
Time Frame
Change from baseline interleukin 1 and 6 level at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André Schmidt, PD Dr
Phone
+41 (0)61 325 59 29
Email
andre.schmidt@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Schmidt, PD Dr
Organizational Affiliation
University of Basel, Department of Psychiatry (UPK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Basel, Department of Psychiatry (UPK)
City
Basel
State/Province
Baselstadt
ZIP/Postal Code
4002
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Schmidt, PD Dr
Phone
+41 (0)61 325 59 29
Email
andre.schmidt@unibas.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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D-serine Supplementation for Depression
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