A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults

ADHD Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01124032
• Other study ID #: SHA 01-10
• Status: Not yet recruiting
• Phase: N/A
• First received: May 13, 2010
• Last updated: May 13, 2010
• Start date: May 2010

Study information

• Verified date: May 2010
• Source: Shalvata Mental Health Center
• Contact: Ziv Carmel, MD
• Phone: 97297478570
• Email: zivca[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• adults in the age of 21-50

Exclusion Criteria:

1. People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.

2. People for whom there is a contra-indication for consuming Ritalin.

3. Pregnant women and nursing women;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• methylphenidate
a capsule containing 20 mg

Locations

Country	Name	City	State
Israel	Shalvata Mental Health center	Hod Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Agay N, Yechiam E, Carmel Z, Levkovitz Y. Non-specific effects of methylphenidate (Ritalin) on cognitive ability and decision-making of ADHD and healthy adults. Psychopharmacology (Berl). 2010 Jul;210(4):511-9. doi: 10.1007/s00213-010-1853-4. Epub 2010 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOVA score		assessed twice, separated by 1-2 weeks.	No
Primary	IGT score		assessed twice, separated by 1-2 weeks	No
Primary	FPGT score		assessed twice, separated by 1-2 weeks	No
Primary	SWM score		assessed twice, separated by 1-2- weeks	No
Primary	digit span score		assessed twice, separated by 1-2- weeks	No