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Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Active Comparator | 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. |
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| Escitalopram | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Encapsulated duloxetine 30 mg, 60 mg; once-daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey R Strawn, MD | Contact | 513-558-4315 | strawnjr@uc.edu | |
| Heidi K Schroeder, BS | Contact | 513-558-4422 | heysehk@uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Strawn, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Double Blind
| Escitalopram | Drug | Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily |
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| D006571 |
| Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |