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Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
NCT04245436 · University of Cincinnati
In plain English
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Official title
Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.
About this study
To identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. And also to examine long-term predictors of sustained response and relapse in adolescents. To examine predictors of developing depressive disorders in anxious adolescents.
Eligibility 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.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2020-01-01
Estimated completion: 2025-08
Last updated: 2024-08-29
Interventions
Drug: DuloxetineDrug: Escitalopram
Primary outcomes
- • Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score (Baseline to Week 24 months (Early Term))
- • Change from Baseline in the Clinical Global Impression of Severity (CGI-S) (Baseline to Week 10 (Early Term))
Sponsor
University of Cincinnati · other
Contacts & investigators
ContactJeffrey R Strawn, MD · contact · strawnjr@uc.edu · 513-558-4315
ContactHeidi K Schroeder, BS · contact · heysehk@uc.edu · 513-558-4422
InvestigatorJeffrey R Strawn, MD · principal_investigator, University of Cincinnati
All locations (1)
University of CincinnatiRecruiting
Cincinnati, Ohio, United States