Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
Study Details
Study Description
Brief Summary
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: Duloxetine
Encapsulated duloxetine 30 mg, 60 mg; once-daily
Other Names:
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| Active Comparator: 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. |
Drug: Escitalopram
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written, informed assent and consent.
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Patients, parent/guardian/LAR must be fluent in the English.
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12 to 17 years of age, inclusive, at Screening.
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Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
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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.
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No clinically significant abnormalities on physical examination.
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Negative pregnancy test at Screening in females.
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Negative urine drug screen at Screening.
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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:
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Surgical sterilization
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Oral contraceptives (e.g. estrogren-progestin combination or progestin)
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Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
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Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
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An intrauterine device
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Diaphragm plus condom.
Exclusion Criteria:
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DSM-512 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.
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A history of intellectual disability.
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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.
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Allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine.
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Subjects taking other medications that require a taper or washout of more than 5 days.
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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.
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A clinically-significant medical illness.
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QTc >450 in males / >460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG81
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Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
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Positive urine pregnancy test/pregnancy or breast feeding.
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A positive urine drug screen.
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Patients who are unable to swallow capsules.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
Sponsors and Collaborators
- University of Cincinnati
Investigators
- Principal Investigator: Jeffrey R Strawn, MD, University of Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Strawn AtLAS-A