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Completed NCT05605938

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

Conditions: Anxiety Disorder of Childhood

Sex: All
Ages: 5 Years – 15 Years
Phase: PHASE4
Enrollment: 98
Sponsor: Materia Medica Holding

Location: Russian Federation

Summary

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

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05605938). StuddyBuddy aggregates publicly available trial information.