Purpose of the study: • evaluate the efficacy and safety of Prospekta in the treatment of attention deficit/hyperactivity disorder in children.
Design: a multicenter double-blind placebo-controlled parallel-group randomized clinical trial. The study will enroll children of either age from 7 to 12 years old with diagnosis of attention deficit/hyperactivity disorder (ADHD) verified by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association" \[DSM-V\]). After signing patient information sheet and informed consent form by the subject's parent/adoptive parent collection of complaints, medical examination of the children, filling Attention Deficit Hyperactivity Disorder-Rating Scale-V \[ADHD-RS-V\]) scale by the parent/adoptive parent will be performed, concomitant therapy will be recorded and laboratory tests will be carried out. The study will enroll children with total score ADHD-RS-V ≥ 22. If the inclusion criteria were met and there were no exclusion criteria (Day 1), the patient will be randomized to one of the two groups: group 1 will receive Prospekta at 1 tablet twice daily; group 2 will receive Placebo using the study drug dosing regimen. Treatment period will be 8 weeks, the key examination stages (collection of complaints, recording objective examination findings, repeated filling ADHD-RS-V by parent/adoptive parent) will be made at Visit 1 (Day 1), further in 4 weeks (visit 2) and in 8 weeks (visit 3). Each visit to the research center will be made by the subject accompanied by his/her parent/adoptive parent. Two weeks later (visit 1.1, week 2±3 days) after randomization and initiation of the study therapy and between visits 2 and 3 (visits 2.2, week 6±3 days) the investigator will examine the patient's clinical status (during phone calls). Based on complaints, monitoring of the prescribed therapy therapeutic safety will be assessed. At visit 2 (week 4±3 days) and visit 3 (week 8±3 days) the investigator will collect complaints, record objective examination findings, monitor repeated ADHD-RS-V filling by parent/adoptive parent, the prescribed and concomitant therapy, evaluate therapeutic safety and compliance. In addition at Visit 3 the investigator will complete the Clinical Global Impression Efficacy Index \[CGI-EI\] scale and collect samples for laboratory testing. The study treatments will be completed. The total length of the observation period is 8 weeks. During the study the treatment for underlying conditions will be allowed with the exception of the drugs indicated in the section "Prohibited concomitant therapy".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
363
Percentage of Patients With Total ADHD-RS-V Reduction ≥25%
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-V). The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). Home version will evaluate behaviour and emotional response in the situations in which the child is with his/her parents. ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home).
Time frame: After 8 weeks of treatment
Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home, with his/her parents). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for scale is to be formed using summations of all items. The maximum possible number of points is 54. The minimum score is 0. Higher score = more severe ADHD symptoms.
Time frame: After 8 weeks of treatment
Change in Total ADHD-RS-V Attention Deficit Subscale Score
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Attention deficit subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity/impulsivity. The attention deficit items are: (1) Attention to detail; (2) Sustaining attention; (3) Does not seem to listen; (4) Follows instructions; (5) Difficulty organizing; (6) Sustained mental effort; (7) Loses things; (8) Distracted; (9) Forgetful. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for attention deficit subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.
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Hospital "Russian Railways - Medicine" of the city of Bryansk
Bryansk, Russia
Regional Clinical Specialized Psychoneurological Hospital # 1/Children's dispensary department
Chelyabinsk, Russia
Engels Psychiatric Hospital
Engel's, Russia
Kazan State Medical University/Department of Neurology, Neurosurgery and Medical Genetics
Kazan', Russia
Children's Republican Clinical Hospital/Neurological department for the treatment of patients with CNS lesions with mental disorders
Kazan', Russia
Specialized Clinical Psychiatric Hospital # 1/Dispensary department
Krasnodar, Russia
Russian National Research Medical University named after N.I. Pirogov/Department of Neurology, Neurosurgery and Medical Genetics, Faculty of Pediatrics
Moscow, Russia
Research and Practical Center of Pediatric Psychoneurology of Moscow City Health Department/Consultative and polyclinic department
Moscow, Russia
Moscow Regional Research Clinical Institute named after M.F. Vladimirsky/Neurology Department of Therapy Department
Moscow, Russia
Llc "Nizhmedklinika"
Nizhny Novgorod, Russia
...and 21 more locations
Time frame: After 8 weeks of treatment
Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Hyperactivity/impulsivity subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. The hyperactivity/impulsivity items are: (1) Fidgets; (2) Leaves seat; (3) Runs about; (4) Playing quietly; (5) On the go; (6) Talks excessively; (7) Blurts out answers; (8) Awaiting turns; (9) Interrupts or intrudes. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for hyperactivity/impulsivity subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.
Time frame: After 8 weeks of treatment
CGI-EI Efficacy Score
Clinical Global Impression Efficacy Index (CGI-EI). Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result. CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines.
Time frame: After 8 weeks of treatment
Changes in Vital Signs (Pulse Rate (Heart Rate))
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
Changes in Vital Signs (Blood Pressure)
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
Based on medical records. Vital signs will be measured in a medical setting.
Time frame: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)
Percentage of Patients With Clinically Relevant Laboratory Abnormalities
Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory.
Time frame: For 8 weeks of the treatment