Treatment for anxiety and depression in adolescents

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

This study tests whether two medications, duloxetine and escitalopram, can help teenagers aged 12 to 17 feel better from anxiety and depression.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT04245436 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of two medications, duloxetine and escitalopram, in treating anxiety and depressive symptoms in adolescents aged 12 to 17. It employs a double-blind, adaptively randomized approach to assess how well these treatments work in the short term, followed by a naturalistic follow-up to evaluate long-term outcomes. The study aims to identify predictors of treatment response and the likelihood of relapse or sustained improvement in these young patients.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 who meet the criteria for anxiety disorders and may also exhibit depressive symptoms.

Not a fit: Patients who do not have anxiety disorders or who have significant physical health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for adolescents suffering from anxiety and depression.

How similar studies have performed: Other studies have shown promise in treating anxiety and depression in adolescents with similar pharmacological approaches, indicating a potential for success.

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.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey R Strawn, MD — University of Cincinnati
• Study coordinator: Jeffrey R Strawn, MD

Conditions Anxiety; Depressive Symptoms