Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)

Inclusion Criteria

• •Written, informed assent and consent.
• •Patients, parent/guardian/LAR must be fluent in the English.
• •12 to 17 years of age, inclusive, at Screening.
• •Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
• •Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
• •No clinically significant abnormalities on physical examination.
• •Negative pregnancy test at Screening in females.
• •Negative urine drug screen at Screening.
• •Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:
• •1. Surgical sterilization
• •2. Oral contraceptives (e.g. estrogren-progestin combination or progestin)
• •3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
• •4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
• •5. An intrauterine device
• •6. Diaphragm plus condom.