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

• Status: Completed
• Trial end date: 2011-10-28
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study:

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

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.