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Pregabalin for the treatment of ADHD

Investigating the Effects of Pregabalin as Adjuvant Therapy in the Treatment of Children with Attention Deficit Hyperactivity Disorder (ADHD): A Double-blind, Placebo-controlled Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N162
Enrollment
50
Registered
2025-03-06
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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: Ritalin, 0.1-3.5 mg per kg of body weight, for the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: ADHD diagnosis based on DSM5 Individuals between 6-11 years old

Exclusion criteria

Exclusion criteria: Presence of severe medical illness, neurological problems and problems requiring surgery Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD History of treatment with pregabalin in the three months prior to the study Consumption neuroleptic medication in the last 6 months Weight less than 13.5 kg Mental retardation Uncontrolled seizure disorder Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute Using any medicine or supplement for the treatment of ADHD History of allergy to methylphenidate or pregabalin

Design outcomes

Primary

MeasureTime frame
Severity of ADHD symptoms. Timepoint: Weeks: 0 , 4 , 8. Method of measurement: By ADHD Rating Scale (by parents or teacher).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. 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