A Phase 4 interventional study of Tenoten for children and Placebo in Anxiety Disorder of Childhood, sponsored by Materia Medica Holding. Completed at 5 sites in Russian Federation. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Materia Medica Holding · Phase 4, Interventional, and Treatment
Purpose of the study:
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 98 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Materia Medica Holding is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
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At least one of the diagnoses from ICD-10 Diagnosis Code F 93 - Emotional disorders with onset specific to childhood:
Mild to severe disease, with the severity assessed using the following scales:
Exclusion Criteria:
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
As per the Tenoten for children dosing regimen.
Drug: Placebo
Oral administration
Oral administration
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
Time frame: 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
Time frame: 12 weeks
Percentage of patients who progress to milder anxiety disorders
Based on medical records
Time frame: 12 weeks
Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders
Based on medical records
Time frame: 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)
Time frame: 12 weeks
Occurrence and characteristics of adverse events
Based on medical records. Occurrence, severity, relationship with medicine, outcomes of adverse events
Time frame: 12 weeks
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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