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

NCT05605938 | Completed Phase 4

• 1 other identifier: MMH-TD-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Anxiety Disorder of Childhood

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders

  12 weeks

• Comparison of mean CGI scores between study groups

  12 weeks

• Occurrence and characteristics of adverse events

  12 weeks

Study Arms (2)

Tenoten for children

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

As per the Tenoten for children dosing regimen.

Drug: Placebo

Interventions

Tenoten for children DRUG

Oral administration

Tenoten for children

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (5)

Specialized Clinical Psychiatric Hospital # 1

Krasnodar, 350007, Russia

Location

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

Moscow, 115522, Russia

Location

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

Moscow, 117997, Russia

Location

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

Moscow, 119991, Russia

Location

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

Saint Petersburg, 197376, Russia

Location

MeSH Terms

Interventions

tenoten

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind placebo-controlled randomized

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: July 28, 2010
• Primary Completion: October 28, 2011
• Study Completion: October 28, 2011
• Last Updated: November 4, 2022

Record last verified: 2022-05

Locations

RU (5)