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

Primary Purpose

Anxiety, Depressive Symptoms

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

Escitalopram

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Duloxetine

Escitalopram

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score

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)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04245436

First Posted

January 7, 2020

Last Updated

September 13, 2023

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT04245436

Brief Title

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

Acronym

AtLAS-A

Official Title

Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depressive Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double Blind

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Active Comparator

Arm Description

Arm Title

Escitalopram

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta, Irenka

Intervention Description

Encapsulated duloxetine 30 mg, 60 mg; once-daily

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score

Description

Time Frame

Baseline to Week 24 months (Early Term)

Title

Change from Baseline in the Clinical Global Impression of Severity (CGI-S)

Description

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

Time Frame

Baseline to Week 10 (Early Term)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey R Strawn, MD

Phone

513-558-4315

strawnjr@uc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Heidi K Schroeder, BS

Phone

513-558-4422

heysehk@uc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey R Strawn, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey R Strawn, MD

Phone

513-558-7700

strawnjr@uc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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