NCT04245436 Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
| NCT ID | NCT04245436 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Cincinnati |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2020-01-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
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.
Contact & Investigator
Jeffrey R Strawn, MD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT04245436 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04245436 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04245436 currently recruiting?
Yes, NCT04245436 is actively recruiting participants. Contact the research team at strawnjr@uc.edu for enrollment information.
Where is the NCT04245436 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04245436 clinical trial?
NCT04245436 is sponsored by University of Cincinnati. The principal investigator is Jeffrey R Strawn, MD at University of Cincinnati. The trial plans to enroll 60 participants.
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