NCT01459029

Brief Summary

The purpose of this study is to compare efficacy and safety of add-on treatment with a moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset schizophrenia patients who suffer from significant symptoms despite treatment with antipsychotics.

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
54

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Nov 2011

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 9, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

October 9, 2011

Last Update Submit

October 24, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaNMDA receptorD-serineRecent onsetNegative symptomsCognition

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the Total Score of the Positive and Negative Syndrome Scale (PANSS)

    Biweekly for 12 weeks

Secondary Outcomes (11)

  • Change from Baseline in the Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery

    12 weeks

  • Change from Baseline in the Subscales of PANSS

    Biweekly for 12 weeks

  • Change from Baseline in the Clinical Global Impressions (CGI)

    Biweekly for 12 weeks

  • Change from Baseline in the Scale for the Assessment of Negative Symptoms (SANS)

    Biweekly for 12 weeks

  • Change from Baseline in the Calgary Depression Scale for Schizophrenia (CDSS

    Biweekly for 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

D-serine

ACTIVE COMPARATOR

D-serine up to 6000 mg/day subject to tolerability

Drug: D-serine

Control

PLACEBO COMPARATOR

Treatment with inert capsules (placebo)

Drug: D-serine

Interventions

D-serineDRUG

Adjuvant treatment with D-serine up to 6000 mg/day vs. placebo

ControlD-serine

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30
  • Diagnosis of schizophrenia/schizoaffective disorder
  • Recent onset (up to five years since onset of positive symptoms)
  • Stable dose antipsychotic treatment for at least 4 weeks
  • Baseline PANSS total score of at least 70
  • Baseline PANSS negative subscale score of at least 20
  • Clinically stable (stable CGI score for two consecutive weeks)

You may not qualify if:

  • Criteria for other DSM-IV Axis I diagnoses are met
  • Lifetime history of alcohol or substance dependence
  • Alcohol or substance abuse within the past year
  • Judged clinically to be at suicidal or homicidal risk
  • Female patients who are pregnant or lactating.
  • Patients with known intolerance to D-serine treatment
  • Patients treated with ECT within 12 weeks prior to study entry
  • Patients treated with TMS within 4 weeks prior to study entry
  • Patients suffering from an unstable and/or untreated medical disorder
  • Patients suffering from renal or hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ezrath Nashim - Herzog Memorial Hospital & Community Clinics

Jerusalem, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Amit Lotan, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Bernard Lerer, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Uriel Heresco-Levy, MD

    Ezrath Nashim - Herzog Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Amit Lotan, MD

CONTACT

00 972 2 6777184amitlo@hadassah.org.il

Bernard Lerer, MD

CONTACT

00 972 2 6777185lerer@cc.huji.ac.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2011

First Posted

October 25, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

IL(2)