Phase
Condition
Depression
Treatment
Escitalopram
Duloxetine
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 separationanxiety disorder and/or panic disorder, confirmed by the MINI-KID.
Caregiver who is willing to consent to be responsible for safety monitoring of thepatient, provide information about the patient's condition, oversee theadministration 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 daysfollowing the end of study participation. Reliable methods of contraception aredefined below; other forms of contraceptives (pharmacological and/ornon-pharmacological) are not accepted:
Surgical sterilization
Oral contraceptives (e.g. estrogren-progestin combination or progestin)
Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g.,Implanon, Norplant II/Jadelle)
An intrauterine device
Diaphragm plus condom.
Exclusion
Exclusion Criteria:
DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxietyor panic disorder(s) that is the primary focus of treatment.
A history of intellectual disability.
Suicide risk as determined by either: (1) any suicide attempt within the past 6months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), asjudged by the Investigator.
Allergy, intolerance, non-response or hypersensitivity to escitalopram orduloxetine.
Subjects taking other medications that require a taper or washout of more than 5days.
Patients who have initiated/terminated psychotherapy/behavior therapy within 1 monthbefore Visit 2 (Baseline), or who plan to initiate/change said therapies during thecourse of the study will be excluded; if the patient is engaged in psychotherapy, itmust have been stable for 1 month prior to baseline.
A clinically-significant medical illness.
QTc >450 in males / >460 in females (prolonged QTc based on American HeartAssociation recommendations for Standardization and Interpretation of the EKG81
Alcohol or substance use disorder within the past 6 months (nicotine use ispermitted).
Positive urine pregnancy test/pregnancy or breast feeding.
A positive urine drug screen.
Patients who are unable to swallow capsules.
Study Design
Study Description
Connect with a study center
University of Cincinnati
Cincinnati, Ohio 45219
United StatesActive - Recruiting

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