Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–45
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Participants meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD and Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD-10) criteria for Autism diagnosis
SRS-2 (T-score) greater than or equal to (\>/=) 66
CGI-S \>/=4 (moderately ill)
Participants have an Intelligence Quotient (IQ) \>/=70 (Wechsler Abbreviated State of Intelligence)
A body mass index (BMI) between 18 to 40 kilograms per square meter (kg/m\^2) inclusive
Language, hearing and vision compatible with the study measurements as judged by the investigator
Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior.
You may not be if
Alcohol and/or substance abuse/dependence during the last 12 months
A significant risk for suicidal behavior, in the opinion of the investigator
Systolic blood pressure greater than (\>) 140 or less than (\<) 90 millimeters of mercury (mm Hg), and diastolic blood pressure \>90 or less than (\<) 50 mm Hg
Resting pulse rate \>90 or \<40 beats per minute
Use of prohibited medications or herbal remedies within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
Initiation of a new major change in psychological intervention within 4 weeks prior to randomization. Minor changes in ongoing treatment are not considered significant
Participation in an investigational drug or device study within 60 days prior to randomization
Clareo Health | A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
