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DSRSZ: D-serine in Schizophrenia

Sponsor
Herzog Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03702933
Collaborator
(none)
40
Enrollment
1
Location
39
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: D-serine

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo

starch

Dietary Supplement: D-serine
dosage
Other Names:
  • placebo

    		•
    High Dose

    3.5 g/d D-serine adjuvant treatment

    Dietary Supplement: D-serine
    dosage
    Other Names:
  • placebo

    		•
    Low Dose

    2.1 g/d D-serine adjuvant treatment

    Dietary Supplement: D-serine
    dosage
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PANSS Total Score [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items
    Exclusion Criteria:
    • clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herzog Hospital Jerusalem Israel 91035

    Sponsors and Collaborators

    • Herzog Hospital

    Investigators

    • Principal Investigator: Uriel Heresco-Levy, MD, Herzog Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heresco-Levi Uriel, Professor of Psychiatry, Herzog Hospital
    ClinicalTrials.gov Identifier:
    NCT03702933
    Other Study ID Numbers:
    • HerzogHospital
    First Posted:
    Oct 11, 2018
    Last Update Posted:
    Oct 11, 2018
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Oct 11, 2018