Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score
研究概览
简要总结
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Surgical sterilization
- •Oral contraceptives (e.g. estrogren-progestin combination or progestin)
- •Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
- •Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
- •An intrauterine device
- •Diaphragm plus condom.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Duloxetine (Drug)
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.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score
时间窗: 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)
时间窗: Baseline to Week 10 (Early Term)
CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
次要结局
未报告次要终点
研究者
Jeffrey Strawn, MD
Associate professor
University of Cincinnati