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

NCT ID: NCT04245436

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-08-31

Brief Summary

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

Detailed 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.

Conditions

Anxiety; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine

Patients randomized to duloxetine, treatment will be initiated at 30 mg qAM through Week 4 (V5) (consistent with the registration trial for duloxetine in pediatric patients with generalized anxiety disorder). Then, duloxetine will be increased to 60 mg qAM at Week 4 (V5) and will be continued at this dose until Week 6 (V6) or the end of the acute phase of the study. Beginning at Week 6 (V6), duloxetine may be increased to 90 mg daily and at Week 8 (V7), may be increased to 120 mg daily.

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

Encapsulated duloxetine 30 mg, 60 mg; once-daily

Escitalopram

Patients randomized to escitalopram, will initiate treatment at 5 mg qAM for 1 week and then 10 mg qAM (the recommended starting dose for adolescents 12-17 years and the dose used in the pediatric registration trials). After Week 4 (V5), escitalopram will be increased to 15 mg and this dose will be continued until either Week 6 (V6) or the end of the acute phase of the study; however, at Week 6 (V6), escitalopram may be increased to 20 mg qAM based on efficacy.

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Interventions

Duloxetine

Encapsulated duloxetine 30 mg, 60 mg; once-daily

Intervention Type: DRUG

Escitalopram

Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Irenka; Lexapro

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Strawn, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey R Strawn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey R Strawn, MD

Role: CONTACT

strawnjr@uc.edu

513-558-4315

Heidi K Schroeder, BS

Role: CONTACT

heysehk@uc.edu

513-558-4422

Facility Contacts

Jeffrey R Strawn, MD

Role: primary

strawnjr@uc.edu

513-558-7700

Other Identifiers

Strawn AtLAS-A

Identifier Type: -

Identifier Source: org_study_id