NCT05605938

Efficacy and Safety of Tenoten in the Treatment of Children With Anxiety Disorders

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the study: • evaluate the efficacy and safety of Tenoten for children in children with anxiety disorders.

Detailed description

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.

Conditions

• Anxiety Disorder of Childhood

Interventions

Type	Name	Description
DRUG	Tenoten for children	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2010-07-28
• Primary completion: 2011-10-28
• Completion: 2011-10-28
• First posted: 2022-11-04
• Last updated: 2022-11-04

Locations

5 sites across 1 country: Russia