Attention Deficit Disorder With HyperactivityPhase 3NCT01675804
Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD
A Phase 3 study testing Computerized cognitive rehabilitation and Ritalin in people with Attention Deficit Disorder With Hyperactivity, run by Allameh Tabatabai University at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 7 to 12 years, men only
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Computerized cognitive rehabilitation and Ritalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- age between 7 and 12
- IQ > 85
Who cannot join
- sever co-morbid disorder
- seizure
- IQ < 85
- disability
- sever medical condition
Trial locations and contacts
1 site in 1 country.
Iran1 site
Counseling and guidence Center of the Department of education of region 9 of Tehran
Tehran, Tehran Province
About this study
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
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).
Read the detailed 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.
- Being tested
- Computerized cognitive rehabilitation, Ritalin, Placebo CACR [PCACR]
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive rehabilitationOther
- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.
RitalinDrug
Also called Immediate release methylphenidate
-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.
Placebo CACR [PCACR]Other
PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive rehabilitation | Experimental | -Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR. Receives: Other: Computerized cognitive rehabilitation |
| Placebo CACR [PCACR] | Placebo comparator | -PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR. Receives: Other: Placebo CACR [PCACR] |
| Ritalin | Experimental | -2 to 3 doses of 10 mg Ritalin tablets per day during two months. Receives: Drug: Ritalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persian software for the continuous performance test [CPT]
The Persian software of CPT is a visual CPT test.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Raven's colored progressive matrices.
Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
Measured: 5 months
Span board task from the Lumosity.com online software (Lumosity.com, 2012)
Measured: 5 months
SNAP-IV scales
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allameh Tabatabai University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saeed Azami, MSc, Principal investigator, Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, IranAlireza Moghadas, PhD, Study director, Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.Faramarz Sohrabi, PhD, Study director, Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.Morteza Nazifi, PhD, Study director, Department of psychology, University of Bojnord, Bojnord, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675804
- Sponsor's protocol ID
- 83-6516
- Status last verified
- Apr 2015
- First submitted
- 29 Jul 2012
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01675804
- Acronym / sponsor ID
- 83-6516
- Keywords
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Allameh Tabatabai UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive rehabilitation | Experimental | Other: Computerized cognitive rehabilitation-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR. |
| Placebo CACR [PCACR] | Placebo comparator | Other: Placebo CACR [PCACR]-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR. |
| Ritalin | Experimental | Drug: Ritalin-2 to 3 doses of 10 mg Ritalin tablets per day during two months. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD diagnosis
- age between 7 and 12
- IQ > 85
Key exclusion criteria (5 listed)
- sever co-morbid disorder
- seizure
- IQ < 85
- disability
- sever medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognitive rehabilitation- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation. | Other | Computerized cognitive rehabilitation |
| RitalinAlso: Immediate release methylphenidate-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months. | Drug | Ritalin |
| Placebo CACR [PCACR]PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training. | Other | Placebo CACR [PCACR] |
Primary outcome
Persian software for the continuous performance test [CPT]
Time frame: 5 months
The Persian software of CPT is a visual CPT test.
Persian software for the Tower of London Test [TOL]
Time frame: 5 months
Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.
Forward/Reversed digit span tasks from the WISC-R testing battery.
Time frame: 5 months
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.
Raven's colored progressive matrices.
Time frame: 5 months
Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
Span board task from the Lumosity.com online software (Lumosity.com, 2012)
Time frame: 5 months
SNAP-IV scales
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeed Azami, MSc principal investigator
Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran
Alireza Moghadas, PhD study director
Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
Faramarz Sohrabi, PhD study director
Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Computerized cognitive rehabilitation and Ritalin in people with Attention Deficit Disorder With Hyperactivity, run by Allameh Tabatabai University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persian software for the continuous performance test [CPT] (time frame: 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.