D-serine in Schizophrenia | NCT03702933

Studies
D-serine in Schizophrenia

NCT03702933

Sponsor

Herzog Hospital

Status

Unknown status

Last Update Posted

Oct 11, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Schizophrenia

Interventions

D-serine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Oct 9, 2018

First Submission Date that Met QC Criteria

Oct 9, 2018

First Posted Date

Oct 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
D-serine	Dietary Supplement	dosage	High Dose Low Dose Placebo

Measure	Description	Time Frame
PANSS Total Score		6 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

schizophrenia patients that do not respond to their treatments

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
andrea durrant, PhD	Contact	972527181489		andy007israel@gmail.com
Uriel Heresco-Levy, MD	Contact	97225316906		urielh@ekmd.huji.ac.il

Overall Officials

Name	Affiliation	Role
Uriel Heresco-Levy, MD	Herzog Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herzog Hospital	Recruiting	Jerusalem		91035	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided