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

Anxiety Clinical Trial

— AtLAS-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245436
• Other study ID #: Strawn AtLAS-A
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: Jeffrey R Strawn, MD
• Phone: 513-558-4315
• Email: strawnjr[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

Drug:
• Duloxetine
Encapsulated duloxetine 30 mg, 60 mg; once-daily
• Escitalopram
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline to Week 24 months (Early Term)
Primary	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.	Baseline to Week 10 (Early Term)