Status:
WITHDRAWN
Sarcosine Preventive Therapy for Individuals At High Risk for Schizophrenia
Lead Sponsor:
Herzog Hospital
Conditions:
Schizophrenias
Psychoses
Eligibility:
All Genders
12-45 years
Phase:
PHASE2
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 ...
Detailed Description
Schizophrenia is a neurodevelopmental disorder that affects approximately 1% of the general population and continues to be one of the major challenges of modern medicine due to the tremendous human su...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Meeting criteria for past or current DSM-IV psychotic disorder
- Judged clinically to suffer from a psychiatric disorder (e.g. ADHD, mania, depression) that could account for the inclusion symptoms
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00276263
Start Date
August 1 2006
End Date
June 1 2009
Last Update
June 4 2014
Active Locations (2)
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1
Ezrath Nashim - Herzog Memorial Hospital
Jerusalem, Israel, 91035
2
Department of Psychiatry, Hadassah Hospital and Community Clinics
Jerusalem, Israel