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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675804
• Other study ID #: 83-6516
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2012
• Last updated: April 3, 2015
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2015
• Source: Allameh Tabatabai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• ADHD diagnosis

• age between 7 and 12

• IQ > 85

Exclusion Criteria:

• sever co-morbid disorder

• seizure

• IQ < 85

• disability

• sever medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Other:
• Computerized cognitive rehabilitation
- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.

Drug:
• Ritalin
-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.

Other:
• Placebo CACR [PCACR]
PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Counseling and guidence Center of the Department of education of region 9 of Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Allameh Tabatabai University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persian software for the continuous performance test [CPT]	The Persian software of CPT is a visual CPT test.	5 months	Yes
Primary	Persian software for the Tower of London Test [TOL]	Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.	5 months	Yes
Primary	Forward/Reversed digit span tasks from the WISC-R testing battery.	Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory.	5 months	Yes
Primary	Raven's colored progressive matrices.	Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.	5 months	Yes
Primary	Span board task from the Lumosity.com online software (Lumosity.com, 2012)		5 months	Yes
Primary	SNAP-IV scales		5 months	Yes