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Anxiety Treatment Study for Adolescents (AtLAS-A)

This study is looking at how well two medications, duloxetine and escitalopram, work to treat anxiety and depressive symptoms in adolescents aged 12 to 17. You could be eligible if you have been diagnosed with certain anxiety disorders like generalized anxiety, social anxiety, separation anxiety, or panic disorder. The researchers will measure success by looking at changes in your anxiety severity scores and how much your overall condition improves over time. The study is currently recruiting about 60 participants, but its exact status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either duloxetine or escitalopram. It is a double-blind study, meaning neither you nor your doctor will know which medication you are receiving at first.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for changes in anxiety severity up to 24 months and overall condition improvement up to 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04245436

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

UNKNOWN
PHASE4Ages 12–17InterventionalTreatment
University of Cincinnati
~60 participants
Updated 2024-08-29 on ClinicalTrials.gov
What's tested:DuloxetineEscitalopram

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score
Measured over Baseline to Week 24 months (Early Term)
+1 more outcome measured

Conditions

Anxiety
Depressive Symptoms

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NCT04245436

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Cincinnati

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey R Strawn, MD · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

Jeffrey R Strawn, MD
[email protected]
513-558-4315
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity scoreBaseline to Week 24 months (Early Term)

    The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)

  • Change from Baseline in the Clinical Global Impression of Severity (CGI-S)Baseline to Week 10 (Early Term)

    CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.