Sarcosine Preventive Therapy for Individuals At High Risk for Schizophrenia

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herzog Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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