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RECRUITINGPhase 2INTERVENTIONAL

Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.

Who May Be Eligible (Plain English)

Who May Qualify: - Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration). - Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms \[SOPS\] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period. - Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period. - Subjects agree to participate in the study and provide written willing to sign a consent form after complete description of the study. For the subject \< 20 years old, a parent also has to provide written willing to sign a consent form. Who Should NOT Join This Trial: - DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition. - History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study. - Clinically significant laboratory screening tests (including blood routine, biochemical tests) - Pregnancy or lactation - Inability to follow protocol Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration). * Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms \[SOPS\] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period. * Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period. * Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject \< 20 years old, a parent also has to provide written informed consent. Exclusion Criteria: * DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition. * History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study. * Clinically significant laboratory screening tests (including blood routine, biochemical tests) * Pregnancy or lactation * Inability to follow protocol

Treatments Being Tested

DRUG

NMDAE

Use of an NMDA enhancer for the treatment of prodromal schizophrenia .

DRUG

Placebo Cap

Use of placebo as a comparator

Locations (1)

Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan