Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD

Allameh Tabatabai University

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Other: Placebo CACR [PCACR]; Drug: Ritalin; Other: Computerized cognitive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01675804

83-6516

Details and patient eligibility

About

Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).

Full description

The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.

Enrollment: 34 patients

Sex: Male

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ADHD diagnosis
• age between 7 and 12
• IQ > 85

Exclusion criteria

• sever co-morbid disorder
• seizure
• IQ < 85
• disability
• sever medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups, including a placebo group

Computerized cognitive rehabilitation

Experimental group

Description:

-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.

Treatment:

Other: Computerized cognitive rehabilitation

Placebo CACR [PCACR]

Placebo Comparator group

Description:

-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.

Treatment:

Other: Placebo CACR [PCACR]

Ritalin

Experimental group

Description:

-2 to 3 doses of 10 mg Ritalin tablets per day during two months.

Treatment:

Drug: Ritalin