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Agomelatine in the treatment of ADHD

Comparing the efficacy of Agomelatine and Ritaline in treating children with ADHD in a randomized double-blinded clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201312181556N55
Enrollment
50
Registered
2013-12-23
Start date
2014-01-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbance of activity and attention. Disturbance of activity and attention

Interventions

Intervention 1: Tablet Agomelatine 25 mg/day as intervention group for 6 weeks. Intervention 2: Tablet Ritalin 20-30 mg/kg/day for 6 weeks as control group.
Treatment - Drugs
Tablet Agomelatine 25 mg/day as intervention group for 6 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diagnosis of ADHD based on DSM-IV and age between 6-17 years old. Exclusion criteria: receiving of any psychotropics drugs during past two weeks; presence of any psychiatric disorders or mental retardation (I.Q. <70) except for ODD; history of allergy to Agomelatine or Ritaline; presence of any medical problem including cardiovascular diseases; presence of uncontrolled seizures; systolic blood pressure more than 120 mm Hg; resting pulse rate less than 60/minute or more than 115/minute; liver enzymes more than normal range.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of ADHD. Timepoint: Week 0 (before treatment) and Weeks 2, 4 and 6 after treatment. Method of measurement: Teacher and Parent ADHD Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

S.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026