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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Citalopram; Dexetimide; Duloxetine Hydrochloride

Criteria

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.

Exclusion Criteria:

• DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxiety or 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 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.

• Allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine.

• Subjects taking other medications that require a taper or washout of more than 5 days.

• Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline), or who plan to initiate/change said therapies during the course of the study will be excluded; if the patient is engaged in psychotherapy, it must 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 Heart Association recommendations for Standardization and Interpretation of the EKG81

• Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).

• Positive urine pregnancy test/pregnancy or breast feeding.

• A positive urine drug screen.

• Patients who are unable to swallow capsules.