Anxiety Disorder of ChildhoodPhase 4NCT05605938
Efficacy and Safety of Tenoten in the Treatment of Children With Anxiety Disorders
A Phase 4 study testing Tenoten for children in people with Anxiety Disorder of Childhood, run by Materia Medica Holding at 5 sites in Russia.
Trial summary
Purpose of the study: evaluate the efficacy and safety of Tenoten for children in children with anxiety disorders. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Anxiety Disorder of Childhood
- What is being tested?
- Tenoten for children
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 5 sitesRussia
- Study dates
- 28 Jul 2010to 28 Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Specialized Clinical Psychiatric Hospital # 1
Krasnodar, 350007
Scientific Center for Mental Health of the Russian Academy of Medical Sciences
Moscow, 115522
Russian National Research Medical University named after N.I. Pirogov
Moscow, 117997
Scientific Center for Children's Health of the Russian Academy of Medical Sciences
Moscow, 119991
Institute of the Human Brain named after N.P. Bekhtereva Russian Academy of Sciences
Saint Petersburg, 197376
About this study
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
Purpose of the study:
- evaluate the efficacy and safety of Tenoten for children in children with anxiety disorders.
Read the 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.
- Conditions
- Anxiety Disorder of Childhood
- Being tested
- Tenoten for children, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoten for childrenDrug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tenoten for children |
| Placebo | Placebo comparator | As per the Tenoten for children dosing regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Percentage of patients who progress to milder anxiety disorders
Based on medical records
Measured: 12 weeks
Secondary outcomes (3)
Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders
Based on medical records
Measured: 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)
Measured: 12 weeks
Occurrence and characteristics of adverse events
Based on medical records. Occurrence, severity, relationship with medicine, outcomes of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start28 Jul 2010
- Primary completion28 Oct 2011
- Study completion28 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo-controlled randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605938
- Sponsor's protocol ID
- MMH-TD-001
- Status last verified
- May 2022
- First submitted
- 25 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05605938
- Acronym / sponsor ID
- MMH-TD-001
- Conditions
- Anxiety Disorder of Childhood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2010 (actual)
- Primary completion
- 28 Oct 2011 (actual)
- Study completion
- 28 Oct 2011 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind placebo-controlled randomized
| Arm | Type | Receives |
|---|---|---|
| Tenoten for children | Experimental | Drug: Tenoten for children1 tablet 3 times daily for 12 weeks. Route of administration: sublingual, the tablet should be held in the mouth until completely dissolved. |
| Placebo | Placebo comparator | Drug: PlaceboAs per the Tenoten for children dosing regimen. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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:
- Mild to severe disease, with the severity assessed using the following scales:
- No signs of severe cognitive development deficiency, according to the investigator;
- No drug treatment for anxiety disorders within the last two weeks;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenoten for childrenOral administration | Drug | Tenoten for children |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Changes in SCAS scores
Time frame: 12 weeks
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
Changes in severity of anxiety according to test of R.Temple, V.Amen, M.Dorky
Time frame: 12 weeks
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
Percentage of patients who progress to milder anxiety disorders
Time frame: 12 weeks
Based on medical records
3 secondary outcomes
Changes in anxiety disorder symptoms according to SCAS domains, depending on type of anxiety disorders
Time frame: 12 weeks
Comparison of mean CGI scores between study groups
Time frame: 12 weeks
Occurrence and characteristics of adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenoten for children in people with Anxiety Disorder of Childhood, run by Materia Medica Holding at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in SCAS scores (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.