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

Materia Medica

Status and phase: Completed; Phase 4

Conditions: Anxiety Disorder of Childhood

Treatments: Drug: Tenoten for children; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05605938

MMH-TD-001

Details and patient eligibility

About

Purpose of the study:

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

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children of both sexes aged 5 to 15 years inclusive.

2. 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.

3. 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;

4. No signs of severe cognitive development deficiency, according to the investigator;

5. No drug treatment for anxiety disorders within the last two weeks;

6. 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

1. Age under 5 or over 15 years;
2. Decompensated somatic diseases that may affect the conduct of the trial;
3. Severe residual signs of organic CNS injury;
4. Hallucinations, delusions, and psychotic affective disorders;
5. Mental retardation and oligophrenic-like impairment;
6. Hypersensitivity to any components of the study drugs;
7. Reluctance of a child or his/her legal representatives to participate in the clinical study;
8. The patient's legal representative with drug abuse problems, alcoholism, or mental disorders;
9. Participation in other clinical studies within 4 months prior to enrollment in the current trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

98 participants in 2 patient groups, including a placebo group

Tenoten for children

Experimental group

Description:

1 tablet 3 times daily for 12 weeks. Route of administration: sublingual, the tablet should be held in the mouth until completely dissolved.

Treatment:

Drug: Tenoten for children

Placebo

Placebo Comparator group

Description:

As per the Tenoten for children dosing regimen.

Treatment:

Drug: Placebo