Clinical trial NCT05605938: Efficacy and Safety of Tenoten in the Treatment of Children With Anxiety Disorders
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety Disorder of Childhood
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 98
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind placebo-controlled randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in SCAS scores
timeFrame: 12 weeks
measure: Changes in severity of anxiety according to test of R.Temple, V.Amen, M.Dorky
timeFrame: 12 weeks
measure: Percentage of patients who progress to milder anxiety disorders
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders
timeFrame: 12 weeks
measure: Comparison of mean CGI scores between study groups
timeFrame: 12 weeks
measure: Occurrence and characteristics of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: Specialized Clinical Psychiatric Hospital # 1
city: Moscow
country: Russian Federation
facility: Scientific Center for Mental Health of the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Russian National Research Medical University named after N.I. Pirogov
city: Moscow
country: Russian Federation
facility: Scientific Center for Children's Health of the Russian Academy of Medical Sciences
city: Saint Petersburg
country: Russian Federation
facility: Institute of the Human Brain named after N.P. Bekhtereva Russian Academy of Sciences
Study officials:
References: