NCT01124032

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

May 13, 2010

Last Update Submit

May 13, 2010

Conditions

ADHD

Outcome Measures

Primary Outcomes (5)

  • TOVA score

    assessed twice, separated by 1-2 weeks.

  • IGT score

    assessed twice, separated by 1-2 weeks

  • FPGT score

    assessed twice, separated by 1-2 weeks

  • SWM score

    assessed twice, separated by 1-2- weeks

  • digit span score

    assessed twice, separated by 1-2- weeks

Study Arms (2)

ADHD adults

EXPERIMENTAL
Drug: methylphenidate

healthy adults

EXPERIMENTAL
Drug: methylphenidate

Interventions

methylphenidateDRUG

a capsule containing 20 mg

ADHD adultshealthy adults

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adults in the age of 21-50

You may not qualify if:

  • People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.
  • People for whom there is a contra-indication for consuming Ritalin.
  • Pregnant women and nursing women;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Mental Health center

Hod HaSharon, Israel

Location

Related 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.

    PMID: 20424828BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ziv Carmel, MD

CONTACT

97297478570zivca@clalit.org.il

Nirit Agay, Msc

CONTACT

97297478644niritag@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

IL(1)