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Examining the effects of Agomelatine drug in hyperactive patients

Investigating the effectiveness of Ritalin and Agomelatine combined treatment in the treatment of children with attention deficit hyperactivity disorder (ADHD).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241024063486N1
Enrollment
40
Registered
2024-11-11
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

ADHD. Attention-deficit hyperactivity disorder, combined type

Interventions

Intervention 1: Intervention group: Agomelatine (Agolyp 25mg tablet), a product of Tadbir Kala Jam Pharmaceutical Company, is administered at a starting dose of 12.5mg daily for patients weighing at l

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 8 to 18 years ADHD disorder based on DSM5 criteria Children with a partial response to Ritalin such that symptoms such as anxiety and mood symptoms remain Normal IQ based on doctor's judgment Minimum weight 30 kilograms

Exclusion criteria

Exclusion criteria: Children who have received Ritalin in the past and have not shown a positive therapeutic response and effectiveness. Interfering physical disorders include: neurological disorders, history of severe hypersensitivity reaction to agomelatine, history of heart disease. A history of major psychiatric illnesses (mood and suicidal ideation disorders, psychotic disorders, substance abuse). Recent use of anti-anxiety and antidepressant medication within the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
Symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Timepoint: At baseline, week 4, and week 8. Method of measurement: Conners’ Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed AbdolSamad Mazloomi

Zanjan University of Medical Sciences

sadra4780@gmail.com+98 24 3301 4101

Outcome results

None listed

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