Sarcosine Preventive Therapy for Individuals At High Risk for Schizophrenia (NCT00276263) | Clinical Trial Compass
WithdrawnPhase 2
Sarcosine Preventive Therapy for Individuals At High Risk for Schizophrenia
Stopped: lack of participants
Israel0Started 2006-08
Plain-language 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.
Who can participate
Age range
12 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sarcosine vs. placebo in subjects at risk for developing schizophrenia:efficacy and safety.
Timeframe: 16 weeks
2
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)
Timeframe: 16 weeks
3
Sarcosine vs. placebo in the treatment of neurocognitive dysfunction