Anxiety Disorders and Symptoms, Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
Mexidol, hyperactivity, ADHD, oppositional defiant disorder, inattention, Neurodevelopmental disorders, Hyperactive behavior, Impulsive behavior, anxiety
Brief summary
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). This multicenter, prospective, double-blind, randomized trial included 333 children who met the diagnostic criteria established by the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Participants received either Mexidol or placebo for 42 days, and various efficacy and safety parameters were assessed.
Interventions
DRUGMexidol
125 mg tablets
DRUGPlacebo
Placebo tablets
DRUGMexidol + Placebo
Combination of Mexidol and Placebo
Sponsors
Pharmasoft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent for participation in the study from the patient's parents. 2. Patients - boys and girls aged 6 to 12 years, inclusive, at the time of signing the informed consent. 3. The child is raised by a father and/or mother. 4. The child is attending general education preschool or school institutions. 5. Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) established in accordance with ICD-10 and DSM-5 criteria by a psychiatrist or neurologist, specifically: \- According to DSM-5: 1. Six or more symptoms of inattention persisting for at least 6 months and/or 2. Six or more symptoms of hyperactivity and impulsivity persisting for at least 6 months 3. Symptoms are present in at least two areas of functioning (in preschool or school and at home). \- And/or according to ICD-10: 4. Presence of at least 6 symptoms of inattention 5. Presence of at least 3 symptoms of hyperactivity 6. Presence of at least 1 symptom of impulsivity 7. Persisting for at least 6 months. 6. Moderate severity of ADHD as determined by the Clinical Global Impression - Severity Scale for ADHD (CGI-ADHD-S), not requiring hospitalization for treatment. 7. No more than two comorbid disorders that do not require additional pharmacotherapy, in the investigator's opinion, during the study period.
Exclusion criteria
Individuals who exhibit at least one of the following characteristics were not included in the study: 1. Increased sensitivity to the active substance of the investigational drug (ethylmethylhydroxypyridine succinate) and/or other components of the drug. 2. Liver dysfunction: ALT and/or AST ≥2.5 times the upper limit of normal (ULN) based on screening lab results. 3. Kidney dysfunction: serum creatinine ≥1.5 times ULN based on screening lab results. 4. Intracranial pathology (including but not limited to: intracranial hemorrhage, tumors, infections, history of head trauma, excluding concussion). 5. Co-occurring autism spectrum disorders, Asperger syndrome. 6. Intellectual disability of any degree. 7. Other mental disorders, except for behavioral disorders (ICD-10 code F91). 8. Inability to discontinue psychotropic medications used for the treatment of ADHD. 9. Other somatic and/or neurological disorders requiring treatment with medications that may affect the efficacy of the investigational drug (including but not limited to: epilepsy, depression). 10. Use of nootropic, vasoactive medications, neuroprotectors, antioxidants, or metabolic agents within 7 days or 5 half-lives (whichever is longer) prior to randomization. 11. Presence of any oncological disease in the medical history within 5 years prior to the screening visit. 12. Participation in any other clinical study of drugs and/or medical devices within 3 months prior to the screening visit and/or 5 half-lives, whichever is longer. 13. Inability or unwillingness to comply with protocol requirements, including for physical, mental, or social reasons, in the opinion of the investigator. 14. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder and oppositional defiant disorder symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores are calculated by summing the scores on the subset and dividing by the number of items in the subset. The main criterion for the treatment efficacy was the mean change in the total score on the inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy. A conclusion of superiority of Mexidol over placebo can be made if the upper limit of the 95% confidence interval for the difference in mean changes is negative. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome. |
| Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 25 point scale: min value 0, max value 24, higher scores mean a worse outcome. |
| Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 31 point scale: min value 0, max value 30, higher scores mean a worse outcome. |
| Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) | The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) is a 39-item parent report measure designed to assess anxiety symptoms in children. Built upon contemporary diagnostic frameworks, the SCAS-Parent evaluates six distinct domains of anxiety that align with clinical diagnostic categories. Each question on the test addresses the frequency of certain anxiety symptoms, measured on a 0-3 scale from never, sometimes, often, to always. SCAS-Parent scores consist of a total raw score (range from 0 to 114) and six sub-scale scores, with higher scores indicating greater severity of anxiety symptoms. 124 point scale: min value 0, max value 123, higher scores mean a worse outcome. |
| Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome. |
| Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) | The Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) is a clinician-rated scale used to assess the severity of Attention Deficit Hyperactivity Disorder (ADHD) symptoms. This tool is part of the Clinical Global Impressions (CGI) scales. It typically consists of a single item that rates the severity of ADHD on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). 7 point scale: min value 1, max value 7, higher scores mean a worse outcome. |
| Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment) | The Clinical Global Impressions (CGI) Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication. It consists of 3 subscales. The subscale Clinical Global Impression-Improvement (CGI-I) is a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. 7 point scale: min value 1, max value 7, higher scores mean a worse outcome. |
| Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit) | The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome. |
| Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit) | The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome. |
| Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) | The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-question inventory used to aid in the diagnosis of attention deficit hyperactivity disorder (ADHD) in children. Each question measures the frequency of the behavior on a 0-3 scale from rarely or never, sometimes, often, to very often. The questionnaire is intended to be filled out by parents and teachers. Higher scores indicate greater severity of ADHD symptoms. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome. |
Countries
Russia
Participant flow
Recruitment details
Participants were recruited based on protocol requirements at 14 clinical sites between July 2019 and May 2020. The first participant was enrolled on 13 July, 2019 and the last participant was enrolled on 22 May, 2020.
Pre-assignment details
Of 340 screened participants, 333 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Main (Mexidol) + Control (Placebo) Participants received Mexidol 125 mg 1 tablet orally once a day and Mexidol Placebo matching Mexidol 125 mg 1 tablet orally once a day for 42 days. | 111 |
| Main (Mexidol) Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. | 111 |
| Control (Placebo) Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. | 111 |
| Total | 333 |
Baseline characteristics
| Characteristic | Main (Mexidol) + Control (Placebo) | Total | Control (Placebo) | Main (Mexidol) |
|---|---|---|---|---|
| ADHD-RS-IV at Visit 2 (Randomization Visit) | 32.55 score on a scale STANDARD_DEVIATION 6.92 | 32.66 score on a scale STANDARD_DEVIATION 6.88 | 32.77 score on a scale STANDARD_DEVIATION 6.88 | 32.68 score on a scale STANDARD_DEVIATION 6.9 |
| Age, Categorical <=18 years | 111 Participants | 333 Participants | 111 Participants | 111 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8 Years | 8 Years | 8 Years | 9 Years |
| CGI-ADHD-S Scale before treatment Level 2 (borderline mentally ill) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| CGI-ADHD-S Scale before treatment Level 3 (mildly ill) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| CGI-ADHD-S Scale before treatment Level 4 (moderately ill) | 111 Participants | 333 Participants | 111 Participants | 111 Participants |
| CGI-ADHD-S Scale before treatment Level 5 (markedly ill) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| PedMIDAS at Visit 2 (Randomization Visit) Maximal headache severity | 5.75 scores on ascale STANDARD_DEVIATION 2.19 | 5.61 scores on ascale STANDARD_DEVIATION 2.03 | 6.14 scores on ascale STANDARD_DEVIATION 2.12 | 4.00 scores on ascale STANDARD_DEVIATION 0 |
| PedMIDAS at Visit 2 (Randomization Visit) Moderate headache severity | 4.25 scores on ascale STANDARD_DEVIATION 2.19 | 3.89 scores on ascale STANDARD_DEVIATION 1.81 | 3.86 scores on ascale STANDARD_DEVIATION 1.68 | 3.00 scores on ascale STANDARD_DEVIATION 1 |
| PedMIDAS at Visit 2 (Randomization Visit) Number of days with a headache | 9.04 days STANDARD_DEVIATION 10.52 | 6.44 days STANDARD_DEVIATION 7.35 | 4.86 days STANDARD_DEVIATION 2.3 | 3.22 days STANDARD_DEVIATION 2.27 |
| PedMIDAS at Visit 2 (Randomization Visit) Number of days with limited daily activities | 10.96 days STANDARD_DEVIATION 19.76 | 5.59 days STANDARD_DEVIATION 13.66 | 1.62 days STANDARD_DEVIATION 1.82 | 0.56 days STANDARD_DEVIATION 0.51 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment Russia | 111 Participants | 333 Participants | 111 Participants | 111 Participants |
| SCAS-Parent at Visit 2 (Randomization Visit) | 13.13 score on a scale STANDARD_DEVIATION 14.84 | 13.22 score on a scale STANDARD_DEVIATION 14.58 | 13.27 score on a scale STANDARD_DEVIATION 13.63 | 13.27 score on a scale STANDARD_DEVIATION 15.36 |
| Sex: Female, Male Female | 37 Participants | 97 Participants | 31 Participants | 29 Participants |
| Sex: Female, Male Male | 74 Participants | 236 Participants | 80 Participants | 82 Participants |
| SNAP-IV, Subscale Connors Index at Visit 1 (Screening) | 12.03 score on a scale STANDARD_DEVIATION 5.11 | 11.92 score on a scale STANDARD_DEVIATION 5.3 | 12.33 score on a scale STANDARD_DEVIATION 5.43 | 11.39 score on a scale STANDARD_DEVIATION 5.36 |
| SNAP-IV, Subscale Hyperactivity/Impulsivity at Visit 1 (Screening) | 14.88 score on a scale STANDARD_DEVIATION 4.27 | 14.96 score on a scale STANDARD_DEVIATION 4.32 | 15.03 score on a scale STANDARD_DEVIATION 4.51 | 14.99 score on a scale STANDARD_DEVIATION 4.22 |
| SNAP-IV, Subscale Inattention at Visit 1 (Screening) | 17.84 score on a scale STANDARD_DEVIATION 3.52 | 17.74 score on a scale STANDARD_DEVIATION 3.69 | 18.00 score on a scale STANDARD_DEVIATION 3.76 | 17.38 score on a scale STANDARD_DEVIATION 3.79 |
| SNAP-IV, Subscale Oppositional Defiant Disorder at Visit 1 (Screening) | 5.16 score on a scale STANDARD_DEVIATION 5.42 | 5 score on a scale STANDARD_DEVIATION 5.33 | 5.24 score on a scale STANDARD_DEVIATION 4.97 | 4.64 score on a scale STANDARD_DEVIATION 5.62 |
| SNAP-IV, Subscales Inattention and Hyperactivity/Impulsivity at Visit 2 (Randomization Visit) | 32.72 score on a scale STANDARD_DEVIATION 6.73 | 32.70 score on a scale STANDARD_DEVIATION 6.93 | 33.03 score on a scale STANDARD_DEVIATION 7.18 | 32.37 score on a scale STANDARD_DEVIATION 6.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 111 | 0 / 111 |
| other Total, other adverse events | 14 / 111 | 26 / 111 | 20 / 111 |
| serious Total, serious adverse events | 0 / 111 | 1 / 111 | 1 / 111 |
Outcome results
Primary
The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level.
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder and oppositional defiant disorder symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores are calculated by summing the scores on the subset and dividing by the number of items in the subset. The main criterion for the treatment efficacy was the mean change in the total score on the inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy. A conclusion of superiority of Mexidol over placebo can be made if the upper limit of the 95% confidence interval for the difference in mean changes is negative. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | SNAP-IV at Visit 5 | 25.41 score on a scale |
| Main (Mexidol) + Control (Placebo) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | Difference at Visit 5 compared to Visit 2 | -7.31 score on a scale |
| Main (Mexidol) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | SNAP-IV at Visit 5 | 23.04 score on a scale |
| Main (Mexidol) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | Difference at Visit 5 compared to Visit 2 | -9.33 score on a scale |
| Control (Placebo) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | SNAP-IV at Visit 5 | 29.10 score on a scale |
| Control (Placebo) | The Average Change in the Total Score Across the Inattention and Hyperactivity/Impulsivity Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level. | Difference at Visit 5 compared to Visit 2 | -3.93 score on a scale |
Secondary
Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale
The Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) is a clinician-rated scale used to assess the severity of Attention Deficit Hyperactivity Disorder (ADHD) symptoms. This tool is part of the Clinical Global Impressions (CGI) scales. It typically consists of a single item that rates the severity of ADHD on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). 7 point scale: min value 1, max value 7, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 2 (borderline mentally ill) | 8 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 3 (mildly ill) | 26 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 4 (moderately ill) | 77 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 5 (markedly ill) | 0 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 5 (markedly ill) | 1 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 2 (borderline mentally ill) | 8 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 4 (moderately ill) | 44 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 3 (mildly ill) | 58 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 5 (markedly ill) | 0 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 3 (mildly ill) | 23 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 4 (moderately ill) | 86 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale | Level 2 (borderline mentally ill) | 2 Participants |
Secondary
Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I)
The Clinical Global Impressions (CGI) Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication. It consists of 3 subscales. The subscale Clinical Global Impression-Improvement (CGI-I) is a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. 7 point scale: min value 1, max value 7, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 2, much improved | 20 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 5, minimally worse | 0 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 4, no change | 27 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 1, very much improved | 3 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 7, very much worse | 0 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 6, much worse | 0 Participants |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 3, minimally improved | 61 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 4, no change | 14 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 1, very much improved | 13 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 2, much improved | 45 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 3, minimally improved | 37 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 5, minimally worse | 1 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 6, much worse | 1 Participants |
| Main (Mexidol) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 7, very much worse | 0 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 5, minimally worse | 3 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 2, much improved | 10 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 7, very much worse | 0 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 6, much worse | 0 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 4, no change | 58 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 3, minimally improved | 38 Participants |
| Control (Placebo) | Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I) | 1, very much improved | 2 Participants |
Secondary
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days
The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Population: The scores on this questionnaire were evaluated only for patients who were found tohave a headache. Thus, the data for comparing the results at the end of the therapy withthe results at the beginning of the therapy were available for 18 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with limited daily activities | 4.25 days | Standard Deviation 10.97 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with limited activity: Visit 5 compared to Visit 2 | -6.71 days | Standard Deviation 11.77 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with a headache | 9.58 days | Standard Deviation 10.73 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with headache: Visit 5 compared to Visit 2 | 0.54 days | Standard Deviation 8.45 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with headache: Visit 5 compared to Visit 2 | 1.89 days | Standard Deviation 4.72 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with limited daily activities | 0.22 days | Standard Deviation 0.38 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with a headache | 5.11 days | Standard Deviation 2.52 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with limited activity: Visit 5 compared to Visit 2 | -0.33 days | Standard Deviation 0.33 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with headache: Visit 5 compared to Visit 2 | 0.10 days | Standard Deviation 3.72 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | No of days with limited activity: Visit 5 compared to Visit 2 | 0.76 days | Standard Deviation 1.46 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with a headache | 4.95 days | Standard Deviation 2.52 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days | Number of days with limited daily activities | 2.38 days | Standard Deviation 2.03 |
Secondary
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity
The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache severity | 3.88 score on a scale | Standard Deviation 2.1 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache: Visit 5 compared to Visit 2 | -0.38 score on a scale | Standard Deviation 1.19 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Maximal headache severity | 6.13 score on a scale | Standard Deviation 3 |
| Main (Mexidol) + Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Max headache: Visit 5 compared to Visit 2 | 0.38 score on a scale | Standard Deviation 1.85 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Max headache: Visit 5 compared to Visit 2 | 1.33 score on a scale | Standard Deviation 2.31 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache severity | 3.00 score on a scale | Standard Deviation 1 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Maximal headache severity | 5.33 score on a scale | Standard Deviation 2.31 |
| Main (Mexidol) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache: Visit 5 compared to Visit 2 | 0.00 score on a scale | Standard Deviation 0 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Max headache: Visit 5 compared to Visit 2 | -0.57 score on a scale | Standard Deviation 1.72 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache: Visit 5 compared to Visit 2 | -0.14 score on a scale | Standard Deviation 0.9 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Maximal headache severity | 5.57 score on a scale | Standard Deviation 1.51 |
| Control (Placebo) | Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity | Moderate headache severity | 3.71 score on a scale | Standard Deviation 1.25 |
Secondary
Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score
The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-question inventory used to aid in the diagnosis of attention deficit hyperactivity disorder (ADHD) in children. Each question measures the frequency of the behavior on a 0-3 scale from rarely or never, sometimes, often, to very often. The questionnaire is intended to be filled out by parents and teachers. Higher scores indicate greater severity of ADHD symptoms. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | ADHD-RS-IV at Visit 5 | 25.23 score on a scale | Standard Deviation 8.01 |
| Main (Mexidol) + Control (Placebo) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | Difference at Visit 5 compared to Visit 2 | -7.32 score on a scale | Standard Deviation 6.15 |
| Main (Mexidol) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | ADHD-RS-IV at Visit 5 | 23.14 score on a scale | Standard Deviation 8.26 |
| Main (Mexidol) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | Difference at Visit 5 compared to Visit 2 | -9.54 score on a scale | Standard Deviation 6.88 |
| Control (Placebo) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | ADHD-RS-IV at Visit 5 | 28.85 score on a scale | Standard Deviation 7.68 |
| Control (Placebo) | Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score | Difference at Visit 5 compared to Visit 2 | -3.92 score on a scale | Standard Deviation 6.16 |
Secondary
Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score
The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) is a 39-item parent report measure designed to assess anxiety symptoms in children. Built upon contemporary diagnostic frameworks, the SCAS-Parent evaluates six distinct domains of anxiety that align with clinical diagnostic categories. Each question on the test addresses the frequency of certain anxiety symptoms, measured on a 0-3 scale from never, sometimes, often, to always. SCAS-Parent scores consist of a total raw score (range from 0 to 114) and six sub-scale scores, with higher scores indicating greater severity of anxiety symptoms. 124 point scale: min value 0, max value 123, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | SCAS-Parent at Visit 5 | 10.23 score on a scale | Standard Deviation 13.66 |
| Main (Mexidol) + Control (Placebo) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | Difference at Visit 5 compared to Visit 2 | -2.90 score on a scale | Standard Deviation 5.45 |
| Main (Mexidol) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | SCAS-Parent at Visit 5 | 10.41 score on a scale | Standard Deviation 15.33 |
| Main (Mexidol) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | Difference at Visit 5 compared to Visit 2 | -2.86 score on a scale | Standard Deviation 6.27 |
| Control (Placebo) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | SCAS-Parent at Visit 5 | 10.22 score on a scale | Standard Deviation 10.64 |
| Control (Placebo) | Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score | Difference at Visit 5 compared to Visit 2 | -3.05 score on a scale | Standard Deviation 6.76 |
Secondary
Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 31 point scale: min value 0, max value 30, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | SNAP-IV), Subscale Connors Index at Visit 5 | 8.71 score on a scale | Standard Deviation 4.83 |
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | Difference at Visit 5 compared to Visit 1 | -3.32 score on a scale | Standard Deviation 2.99 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | SNAP-IV), Subscale Connors Index at Visit 5 | 8.21 score on a scale | Standard Deviation 5.39 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | Difference at Visit 5 compared to Visit 1 | -3.18 score on a scale | Standard Deviation 3.17 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | SNAP-IV), Subscale Connors Index at Visit 5 | 10.33 score on a scale | Standard Deviation 4.57 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Connors Index | Difference at Visit 5 compared to Visit 1 | -2.00 score on a scale | Standard Deviation 3.37 |
Secondary
Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | SNAP-IV, Subscale Hyperactivity/Impulsivity at Visit 5 | 11.38 score on a scale | Standard Deviation 5.06 |
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | Difference at Visit 5 compared to Visit 1 | -3.50 score on a scale | Standard Deviation 3.36 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | SNAP-IV, Subscale Hyperactivity/Impulsivity at Visit 5 | 10.20 score on a scale | Standard Deviation 4.58 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | Difference at Visit 5 compared to Visit 1 | -4.79 score on a scale | Standard Deviation 3.64 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | SNAP-IV, Subscale Hyperactivity/Impulsivity at Visit 5 | 13.15 score on a scale | Standard Deviation 4.76 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Hyperactivity/Impulsivity | Difference at Visit 5 compared to Visit 1 | -1.87 score on a scale | Standard Deviation 3.28 |
Secondary
Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 25 point scale: min value 0, max value 24, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | SNAP-IV, Subscale Oppositional Defiant Disorder at Visit 5 | 4.06 score on a scale | Standard Deviation 4.91 |
| Main (Mexidol) + Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | Difference at Visit 5 compared to Visit 1 | -1.10 score on a scale | Standard Deviation 2.5 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | SNAP-IV, Subscale Oppositional Defiant Disorder at Visit 5 | 3.69 score on a scale | Standard Deviation 4.88 |
| Main (Mexidol) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | Difference at Visit 5 compared to Visit 1 | -0.95 score on a scale | Standard Deviation 2.57 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | SNAP-IV, Subscale Oppositional Defiant Disorder at Visit 5 | 4.43 score on a scale | Standard Deviation 4.48 |
| Control (Placebo) | Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Oppositional Defiant Disorder | Difference at Visit 5 compared to Visit 1 | -0.81 score on a scale | Standard Deviation 2.78 |
Secondary
Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention
The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | SNAP-IV, Subscale Inattention at Visit 5 | 14.04 score on a scale | Standard Deviation 3.79 |
| Main (Mexidol) + Control (Placebo) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | Difference at Visit 5 compared to Visit 1 | -3.80 score on a scale | Standard Deviation 3.62 |
| Main (Mexidol) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | SNAP-IV, Subscale Inattention at Visit 5 | 12.84 score on a scale | Standard Deviation 4.5 |
| Main (Mexidol) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | Difference at Visit 5 compared to Visit 1 | -4.54 score on a scale | Standard Deviation 3.87 |
| Control (Placebo) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | SNAP-IV, Subscale Inattention at Visit 5 | 15.95 score on a scale | Standard Deviation 3.85 |
| Control (Placebo) | Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale Inattention | Difference at Visit 5 compared to Visit 1 | -2.05 score on a scale | Standard Deviation 3.55 |