NCT03702933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

October 9, 2018

Last Update Submit

October 9, 2018

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • PANSS Total Score

    6 weeks

Study Arms (3)

Placebo

starch

Dietary Supplement: D-serine

High Dose

3.5 g/d D-serine adjuvant treatment

Dietary Supplement: D-serine

Low Dose

2.1 g/d D-serine adjuvant treatment

Dietary Supplement: D-serine

Interventions

D-serineDIETARY_SUPPLEMENT

dosage

Also known as: placebo
High DoseLow DosePlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

schizophrenia patients that do not respond to their treatments

You may qualify if:

  • 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

You may not qualify if:

  • clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital

Jerusalem, 91035, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Uriel Heresco-Levy, MD

    Herzog Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

andrea durrant, PhD

CONTACT

972527181489andy007israel@gmail.com

Uriel Heresco-Levy, MD

CONTACT

97225316906urielh@ekmd.huji.ac.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 11, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

IL(1)