Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of the Efficacy and Safety of Tenoten for Children in 12-week Treatment of Children With Anxiety Disorders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 5
- 主要终点
- Percentage of patients who progress to milder anxiety disorders
研究概览
简要总结
Purpose of the study:
• evaluate the efficacy and safety of Tenoten for children in children with anxiety disorders.
详细描述
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized clinical trial.
The study includs children of both sexes aged 5 to 15 years who were diagnosed by a neurologist with an anxiety disorder (according to the ICD-10, one of the variants of an emotional disorder with an onset specific to childhood - F 93).
After a parent/legal representative signed an informed consent form for participation in the clinical trial at the screening visit (Visit 1, Day 0), patients underwent an initial examination, including medical history, assessment of vital signs, and physical examination; concomitant therapy was recorded. The initial severity of anxiety disorders (from mild to severe) was assessed using a scale for assessing the severity of anxiety in children (G.P. Lavrentieva, T.M. Titarenko), using an anxiety test (R. Temple, V. Amen, M. Dorki) and Spence Children's Anxiety Scale (SCAS). If the inclusion criteria were met and no exclusion criteria were met, the patient was included in the study and randomized to one of the groups: Tenoten for children or Placebo (day 0, visit 1). In the course of treatment, patients made 3 visits to the doctor within 12 weeks (at 4, 8 and 12 weeks), during which the dynamics of the severity of anxiety disorders were recorded using an anxiety test (R. Temple, V. Amen, M. Dorki) and SCAS; vital signs and physical examination were performed, prescribed and concomitant therapy were controlled. At visit 4 (week 12), doctor assessed the therapeutic dynamics and treatment side effects by the end of the treatment period in scores on the Clinical Global Impression (CGI) scale.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes aged 5 to 15 years inclusive.
- •At least one of the diagnoses from ICD-10 Diagnosis Code F 93 - Emotional disorders with onset specific to childhood:
- •Separation anxiety disorder of childhood - F 93.0;
- •Phobic anxiety disorder of childhood - F 93.1;
- •Social anxiety disorder of childhood - F 93.2;
- •Generalized anxiety disorder of childhood - F 93.
- •Mild to severe disease, with the severity assessed using the following scales:
- •Child Anxiety Scale of G.P. Lavrentieva and T.M. Titarenko;
- •anxiety test of R. Temple, V. Amen, M. Dorky;
- •No signs of severe cognitive development deficiency, according to the investigator;
- •No drug treatment for anxiety disorders within the last two weeks;
- •Availability of singed informed consent from the legal representative of a child. In addition, patients aged ≥14 years are to sign a patient informed consent form.
排除标准
- •Age under 5 or over 15 years;
- •Decompensated somatic diseases that may affect the conduct of the trial;
- •Severe residual signs of organic CNS injury;
- •Hallucinations, delusions, and psychotic affective disorders;
- •Mental retardation and oligophrenic-like impairment;
- •Hypersensitivity to any components of the study drugs;
- •Reluctance of a child or his/her legal representatives to participate in the clinical study;
- •The patient's legal representative with drug abuse problems, alcoholism, or mental disorders;
- •Participation in other clinical studies within 4 months prior to enrollment in the current trial.
研究组 & 干预措施
Tenoten for children
1 tablet 3 times daily for 12 weeks. Route of administration: sublingual, the tablet should be held in the mouth until completely dissolved.
干预措施: Tenoten for children (Drug)
Placebo
As per the Tenoten for children dosing regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients who progress to milder anxiety disorders
时间窗: 12 weeks
Based on medical records
Changes in SCAS scores
时间窗: 12 weeks
Spence Children's Anxiety Scale (SCAS).The study uses 3 scales: (1) for patients aged 5-7 years and (2) for patients aged 8-15 (both of them filled in by patient's legal representatives); (3) for patients aged 8-15 years (filled in by patient). Maximum total score of each scales is 114. A higher score reflects a higher level of anxiety
Changes in severity of anxiety according to test of R.Temple, V.Amen, M.Dorky
时间窗: 12 weeks
The questionnaire is filled in by legal representative of patient. Each "yes" answer means 1 point. Severe anxiety 15-20 points; moderate 7-14 points; mild 1-6 points
次要结局
- Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders(12 weeks)
- Occurrence and characteristics of adverse events(12 weeks)
- Comparison of mean CGI scores between study groups(12 weeks)