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

STATUS

Recruiting
participants needed

60
sponsor

University of Cincinnati

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Updated on 19 February 2024

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depressive symptoms

anxiety

antidepressants

citalopram

panic disorder

duloxetine

depo-provera

progestin

separation

urine drug screen

norplant

escitalopram

nuvaring

evra

implanon

oral contraceptives

Summary

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

Description

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.

Details

Condition	Depression, Depression, ANXIETY NEUROSIS, Anxiety
Age	12-17 years
Treatment	Duloxetine, Escitalopram
Clinical Study Identifier	NCT04245436
Sponsor	University of Cincinnati
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Written, informed assent and consent
	Patients, parent/guardian/LAR must be fluent in the English
	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
	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 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

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