D-serine in Schizophrenia (DSRSZ)

October 9, 2018 updated by: Heresco-Levi Uriel, Herzog Hospital

The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

schizophrenia patients that do not respond to their treatments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PANSS Total Score
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herzog Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (ACTUAL)

October 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HerzogHospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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