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Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin

Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201110127462N2
Enrollment
40
Registered
2011-10-19
Start date
2011-10-23
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

attention deficiency hyperactivity disorder. Disturbance of activity and attention

Interventions

Intervention 1: Intervention group: Duloxetine 1/4 capsule in the first week, 1/2 capsule in second week, 3/4 capsule in third week and 1 capsule in fourth week. Intervention 2: Control group: accordi
if the weight of patient is more than 30 kg, 3 capsule will be daily prescribed for the third week (1 capsule in the morning and 1 capsule at noon and 1 capsule in the afternoon).
Treatment - Drugs
Intervention group: Duloxetine 1/4 capsule in the first week, 1/2 capsule in second week, 3/4 capsule in third week and 1 capsule in fourth week
Control group: according to Ritalin dosage 0.4-1.3 mg/kg, Ritalin 1 capsule for the first week (1/2 in the morning and 1/2 at noon), 2 capsule for the second week (1 capsule in the morning and 1 capsu
if the weight of patient is more than 30 kg, 3 capsule will be daily prescribed for the third week (1 capsule in the morning and 1 capsule at noon and 1 capsule in the afternoon)

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diagnostic criteria based on DSM IV for children with ADHD, age range 11-18, no consumption of any effective psychological drugs in past two week Exclusion criteria: mental retardation, any other psychological disorders except for ODD, history of allergy to Duloxetine, serious medical conditions such as heart disease, uncontrolled convulsive disorder, systolic pressure upper than 125 mmhg or resting pulse less than 60 or more than 115 bit/m

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Attention deficiency hyperactivity disorder. Timepoint: Baseline, 2, 4, 6, 8 weeks after treatment. Method of measurement: CANERS test for parents (summerized and edited format) and ADHD rating scale for parents and teacher.

Secondary

MeasureTime frame
Drugs side effects. Timepoint: Baseline, 2,4,6,8 weeks after treatment. Method of measurement: side effect questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRozita Jalilian

Psychiatry research center, Tehran University of Medical Sciences

rozita_jalilian@yahoo.com+98 21 5541 3540

Outcome results

None listed

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