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D-serine Supplementation for Depression

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ClinicalTrials.gov Identifier: NCT04721249
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
André Schmidt, Psychiatric Hospital of the University of Basel

Tracking Information
First Submitted Date  ICMJE January 15, 2021
First Posted Date  ICMJE January 22, 2021
Last Update Posted Date January 22, 2021
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
Depression Severity [ Time Frame: Change from baseline HAM-D score at 6 weeks ]
measured with the Hamilton Depression Rating Scale (HAM-D)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
  • Anxiety [ Time Frame: Change from baseline STAI score at 6 weeks ]
    measured with the State-and Trait-Anxiety Inventory (STAI)
  • Anhedonia [ Time Frame: Change from baseline SHAPS score at 6 weeks ]
    measured with the Snaith-Hamilton-Pleasure Scale (SHAPS)
  • Neurocognition [ Time Frame: Change from baseline VLMT score at 6 weeks ]
    measured with the Verbal Learning and Memory Test (VLMT)
  • Prefrontal glutamate concentration [ Time Frame: Change from baseline glutamate level at 6 weeks ]
    measured with magnetic resonance spectroscopy (MRS)
  • Stress level [ Time Frame: Change from baseline cortisol level at 6 weeks ]
    measured with Cortisol awakening responses
  • Inflammation [ Time Frame: Change from baseline interleukin 1 and 6 level at 6 weeks ]
    measured with the blood levels of interleukin 1 and 6
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D-serine Supplementation for Depression
Official Title  ICMJE A Randomized add-on Trial of D-serine for Depression
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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).
  • Dietary Supplement: 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.
Study Arms  ICMJE
  • Active Comparator: Verum
    Intervention: Dietary Supplement: D-serine
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2021)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: André Schmidt, PD Dr +41 (0)61 325 59 29 andre.schmidt@unibas.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04721249
Other Study ID Numbers  ICMJE AS-2124
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party André Schmidt, Psychiatric Hospital of the University of Basel
Study Sponsor  ICMJE André Schmidt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Psychiatric Hospital of the University of Basel
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP