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

NCT ID: NCT05605938

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-28
• Study Completion Date: 2011-10-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tenoten for children

Intervention Type: DRUG

Oral administration

Placebo

As per the Tenoten for children dosing regimen.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration

Interventions

Tenoten for children

Oral administration

Intervention Type: DRUG

Placebo

Oral administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Specialized Clinical Psychiatric Hospital # 1

Krasnodar, , Russia

Scientific Center for Mental Health of the Russian Academy of Medical Sciences

Moscow, , Russia

Russian National Research Medical University named after N.I. Pirogov

Moscow, , Russia

Scientific Center for Children's Health of the Russian Academy of Medical Sciences

Moscow, , Russia

Institute of the Human Brain named after N.P. Bekhtereva Russian Academy of Sciences

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

MMH-TD-001

Identifier Type: -

Identifier Source: org_study_id