NCT00276263

Brief Summary

The purpose of this study is to determine whether preventative treatment with sarcosine can reduce symptoms and delay/avoid disease progression in individuals defined as being in a prodromal stage of schizophrenia.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

First QC Date

January 12, 2006

Last Update Submit

June 3, 2014

Conditions

SchizophreniasPsychosesPsychotic DisordersSchizophrenic Disorders

Keywords

Schizophrenia prodromeSarcosinePsychosisNMDA receptorPrevention

Outcome Measures

Primary Outcomes (3)

  • Sarcosine vs. placebo in subjects at risk for developing schizophrenia:efficacy and safety.

    16 weeks

  • Sarcosine is superior to placebo in the treatment of positive, negative, and cognitive (disorganized) symptoms. Safety assessed with UKU scale, vital signs measurements and laboratory parameters (SMA-20, CBC, UA)

    16 weeks

  • Sarcosine vs. placebo in the treatment of neurocognitive dysfunction

    16 weeks

Secondary Outcomes (1)

  • To assess the efficacy of sarcosine in delay/prevention of illness progression.

    16 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Sarcosine (N-methylglycine)

Interventions

Sarcosine (N-methylglycine)DRUG

Randomization to two treatment groups. One group treated with sarcosine 2 g/day for 16 weeks, the other group treated with placebo 2 g/day for 16 weeks.

1

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Treatment-seeking male or female outpatients, 12-45 years old
  • Meet the definition of one or more prodromal syndromes according to the Criteria of Prodromal Syndromes (COPS) derived using the SIPS/SOPS scales.
  • Possession of a level of understanding sufficient to communicate with the investigator and to understand the nature of the study
  • Agreement to participate in the study and sign informed consent. Minors will be required to give written informed consent with written consent from a parent or guardian

You may not qualify if:

  • Meeting criteria for past or current DSM-IV psychotic disorder
  • Judged clinically to be at suicidal or homicidal risk
  • Symptoms judged clinically to be sequelae of drug or alcohol abuse
  • IQ of less than 80
  • Seizure disorder without a clear or resolved etiology
  • Female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception
  • Taking non-protocol psychiatric medications within two weeks of randomization or depot psychiatric medications three months prior to study entry
  • Individuals suffering from an unstable and/or untreated medical disorder will not be entered in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ezrath Nashim - Herzog Memorial Hospital

Jerusalem, 91035, Israel

Location

Department of Psychiatry, Hadassah Hospital and Community Clinics

Jerusalem, Israel

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

N-substituted GlycinesGlycineAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Uriel Heresco-Levy, M.D.

    Ezrath Nashim - Herzog Hospital / Hadassah Medical School

    PRINCIPAL INVESTIGATOR

  • Bernard Lerer, M.D.

    Department of Psychiatry, Hadassah Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Uriel Heresco-Levy

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

August 1, 2006

Study Completion

June 1, 2009

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

IL(2)