| Eligibility |
Inclusion Criteria:
- Subject has a diagnosis of a 22q11.2 deletion prior to screening.
- Subject has a diagnosis of anxiety disorder and/or ADHD and/or ASD based upon
diagnostic evaluations performed at screening, history, and clinical judgement.
- Subject is judged to be in general good health, other than having anxiety disorder
and/or ADHD and/or ASD and 22q11DS. Medical conditions related to 22q11DS must be
clinically stable post surgical correction and/or medical management.
- Subject has no clinically significant abnormality on 12-lead electrocardiogram (ECG)
performed at screening or baseline such as serious arrhythmia, bradycardia,
tachycardia, cardiac conduction problems, or other abnormalities deemed to be a
potential safety issue.
- Subject and parent/legal guardian understand the study procedures and agree to the
subject's participation in the study as indicated by parental/legal guardian signature
on the subject informed consent form and subject's signature on the assent form.
Exclusion Criteria:
- Subject has a diagnosis of co-morbid major psychiatric disorders (ie, aside from
anxiety disorder, ADHD, and/or ASD), including major depression, bipolar disease,
schizophrenia (or any psychotic disorder), and moderate or severe intellectual
disability, which in the opinion of the investigator may interfere with the conduct of
study evaluations.
- Subject has an IQ < 65 as determined by the Wechsler Abbreviated Scale of
Intelligence.
- Subject has a history of any illness that, in the opinion of the study investigator,
might confound the results of the study or pose an additional risk to the subject by
his/her participation in the study.
- Subject has a history of clinically significant endocrine, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or disease which is not currently stable clinically.
Subjects with a history of uncomplicated kidney stones may be enrolled in the study at
the discretion of the investigator.
- Subject has a history of stroke, chronic seizures, or other major neurological
disorder which, in the opinion of the investigator, would interfere with the subject's
ability to participate and/or be evaluated in the trial.
- Subject is currently considered at risk for suicide (in the opinion of the
investigator), has previously made a suicide attempt, or is currently demonstrating
active suicidal ideation.
- Subject has taken any antidepressants, antipsychotics, anxiolytics, or non-stimulant
ADHD medication within 30 days of the Screening Visit.
- Subject is taking a prohibited medication
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