Efficacy and Safety of Tenoten in the Treatment of Children With Anxiety Disorders
Anxiety Disorder of Childhood
About this trial
This is an interventional treatment trial for Anxiety Disorder of Childhood
Eligibility Criteria
Inclusion Criteria: 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 93.8. 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. Exclusion Criteria: 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.
Sites / Locations
- Specialized Clinical Psychiatric Hospital # 1
- Scientific Center for Mental Health of the Russian Academy of Medical Sciences
- Russian National Research Medical University named after N.I. Pirogov
- Scientific Center for Children's Health of the Russian Academy of Medical Sciences
- Institute of the Human Brain named after N.P. Bekhtereva Russian Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tenoten for children
Placebo
1 tablet 3 times daily for 12 weeks. Route of administration: sublingual, the tablet should be held in the mouth until completely dissolved.
As per the Tenoten for children dosing regimen.