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

Purpose of the study:

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorder of Childhood
• Intervention / Treatment: Drug: Placebo; Drug: Tenoten for children

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Krasnodar, Russian Federation, 350007
    • Specialized Clinical Psychiatric Hospital # 1
  • Moscow, Russian Federation, 117997
    • Russian National Research Medical University named after N.I. Pirogov
  • Moscow, Russian Federation, 115522
    • Scientific Center for Mental Health of the Russian Academy of Medical Sciences
  • Moscow, Russian Federation, 119991
    • Scientific Center for Children's Health of the Russian Academy of Medical Sciences
  • Saint Petersburg, Russian Federation, 197376
    • Institute of the Human Brain named after N.P. Bekhtereva Russian Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tenoten for children; Oral administration
Placebo Comparator: Placebo; As per the Tenoten for children dosing regimen.	Drug: Placebo; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in SCAS scores	Spence Children's Anxiety Scale (SCAS).The study uses 3 scales: (1) for patients aged 5-7 years and (2) for patients aged 8-15 (both of them filled in by patient's legal representatives); (3) for patients aged 8-15 years (filled in by patient). Maximum total score of each scales is 114. A higher score reflects a higher level of anxiety	12 weeks
Changes in severity of anxiety according to test of R.Temple, V.Amen, M.Dorky	The questionnaire is filled in by legal representative of patient. Each "yes" answer means 1 point. Severe anxiety 15-20 points; moderate 7-14 points; mild 1-6 points	12 weeks
Percentage of patients who progress to milder anxiety disorders	Based on medical records	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders	Based on medical records	12 weeks
Comparison of mean CGI scores between study groups	Clinical Global Impression (CGI) scale consists of three subscales: severity of condition, overall degree of its improvement on 7-point system, and subscale of the efficacy index, which is calculated from the combination of one of four degrees of therapeutic effect (noticeable, moderate, minimal, no change) and severity of the side effect drug (absent, insignificant, significant, leveling therapeutic effect)	12 weeks
Occurrence and characteristics of adverse events	Based on medical records. Occurrence, severity, relationship with medicine, outcomes of adverse events	12 weeks

Collaborators and Investigators

• Sponsor: Materia Medica Holding

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2010
• Primary Completion (Actual): October 28, 2011
• Study Completion (Actual): October 28, 2011

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MMH-TD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No