Anxiety, Depressive Symptoms
Conditions
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.
Interventions
DRUGDuloxetine
Encapsulated duloxetine 30 mg, 60 mg; once-daily
DRUGEscitalopram
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score | Baseline to Week 24 months (Early Term) | 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) | Baseline to Week 10 (Early Term) | CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients. |
Countries
United States
Contacts
Primary ContactJeffrey R Strawn, MD
Backup ContactHeidi K Schroeder, BS
Outcome results
None listed