Attention Deficit Disorder with Hyperactivity
Conditions
Interventions
Randomized, crossover, double-blind, placebo-controlled clinical trial, in which 27 subjects aged 7 to 12 years were recruited, of which 22 completed the study. For inclusion in the study, all partici
and the group that received citicoline, started to receive placebo for 28 days (crossover). Both participants and evaluator researchers were blinded to substance use. Randomization was performed by a
D02.092.877.883.333.130
Sponsors
Universidade do Vale do Taquari - Univates
Universidade do Vale do Taquari - Univates
Eligibility
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-5 criteria, confirmed by the investigator's judgment. Age between 7 and 12 years old. Both genders. Subjects using psychopharmacological treatment considered adequate by the investigator, in a stable dose for at least 4 weeks before inclusion, with no need to adjust the dose throughout the study
Exclusion criteria
Exclusion criteria: Other comorbidities that influence the neuropsychological assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: An improvement in attention, hyperactivity and impulsivity is expected after using citicoline for 28 days, evaluated using the scales: abbreviated Wechsler scale, subtest digits of the Wechsler scale and continuous performance test. The sample calculation was based on the formula for comparing two means, with 5% significance, 80% power and 0.8 effect size. For statistical analysis, the Statistical Package for the Social Sciences program will be used, and a parametric test (t test) will be used to test the hypotheses;Outcome found 1: There was no improvement, with statistical significance, in attention, hyperactivity and impulsivity of patients who used citicoline for 28 days, evaluated using the scales: abbreviated Wechsler scale, subtest digits of the Wechsler scale and continuous performance test. Statistical analyzes were performed using the Statistical Package for the Social Sciences program and the parametric test (t test) was used | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome 2: It is expected that patients who use citicoline for 28 days will have good tolerability and will not have adverse effects, which will be evaluated by the researchers when questioning the participants during the study;Secondary outcome found 2: Patients who used citicoline for 28 days had good tolerability and did not have adverse effects, which was evaluated by the researchers when questioning the participants during the study | — |
Countries
Brazil
Contacts
Public ContactIsabel Hübner
Universidade do Vale do Taquari - Univates
Outcome results
None listed