Neural Biomarkers in Fragile X Syndrome

Exclusion Criteria

• •Personal history of infantile spasms/convulsions/epilepsy, severe head trauma or CNS infections (e.g. meningitis), with the exception of infantile febrile seizures.
• •Subjects with a current diagnosis including severe autism spectrum disorder or any primary psychiatric diagnosis according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-DSM-5). Diagnoses that are secondary, such as attention deficit hyperactivity disorder, depressive disorders and conduct disorders are allowed as long as they are considered to not interfere with study conduct and are stable during the 3 months before inclusion. Related allowed treatments must be on stable dosing for the last 3 months.
• •Substance use disorder according to the DSM-5 criteria.
• •Epileptiform abnormalities (excluding isolated sharp waves and beyond those expected for age).
• •Any life-threatening disease.
• •Any other clinically relevant concomitant disease or condition or finding at screening that in the judgment of the investigator could interfere with, the treatment thereof might interfere with, the conduct of the study and related procedures and/or might bias the study results interpretation, or could jeopardize the subject's safety.
• •Any clinically significant findings in physical examination including vital signs.
• •Neuroleptic or antidepressant (ISRS) drugs within 3 months before inclusion, except for sertraline at a maximum 100 mg/day, and stable for the last 3 months before inclusion.
• •Any prescription or over-the-counter drug (except occasional use of paracetamol) in the last 2 weeks before screening.
• •Patient included in a clinical study with drugs in the last three months prior to inclusion.
• •Life-time clinically significant cardiovascular, renal, pulmonary, hepatic, onco-haematological, endocrine, gastrointestinal, mental or neurological disease.
• •Any other clinically relevant concomitant disease or condition or finding at screening that in the judgment of the investigator could interfere with, the treatment thereof might interfere with, the conduct of the study and related procedures and/or might bias the study results interpretation, or could jeopardize the subject's safety.
• •Any clinically significant findings in physical examination including vital signs.
• •Neuroleptic drugs within 3 months prior to inclusion.
• •Any prescription or over-the-counter drug (except occasional use of paracetamol) in the last 2 weeks before screening.
• •Patient included in a clinical study with drugs in the last three months before inclusion.
• •Personal history of infantile spasms/convulsions/epilepsy, severe head trauma or CNS infections (e.g. meningitis), except for infantile febrile seizures.
• •Subjects with a current diagnosis including autism spectrum disorder or any primary psychiatric diagnosis according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-DSM-5). Diagnoses that are secondary, such as attention deficit hyperactivity disorder, depressive disorders and conduct disorders are allowed as long as they are considered to not interfere with study conduct and are stable during the 3 months before inclusion. Related allowed treatments must be on stable dosing for the last 3 months.
• •Substance use disorder according to the DSM-5 criteria except for mild alcohol use disorder and/or mild or moderate nicotine use disorder.
• •Positive urine test for drugs of abuse or alcohol breath test at screening.
• •Epileptiform abnormalities (excluding isolated sharp waves and beyond those expected for age).
• •Any life-threatening disease.