The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults

NCT01040702 | Completed Phase 1 DMC

• 1 other identifier: SH-40107
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• score in decision-making task 1

  by the end of the task

Secondary Outcomes (1)

• working memory task score

  by the end of the task

Study Arms (4)

ADHD -MPH

EXPERIMENTAL

adults with ADHD diagnosis who receive a single dose of Methylphenidate

Drug: methylphenidate

ADHD-placebo

PLACEBO COMPARATOR

adults with ADHD diagnosis who received placebo

Dietary Supplement: sweetener pill

non-ADHD-MPH

EXPERIMENTAL

healthy adults who received a single dose of Methylphenidate

Drug: methylphenidate

non-ADHD-placebo

PLACEBO COMPARATOR

healthy adults who received placebo

Dietary Supplement: sweetener pill

Interventions

methylphenidate DRUG

a single doses of 10-20 mg in each one of two visits

Also known as: Ritalin

ADHD -MPH; non-ADHD-MPH

sweetener pill DIETARY_SUPPLEMENT

a capsule containing a sweetener pill

Also known as: sukrazit

ADHD-placebo; non-ADHD-placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults in the age of 21-50

You may not qualify if:

• pregnant or nursing women.
• people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.
• people who lack judgment or are unable to communicate with the experimenters.
• people who are incapable of performing the computerized tasks due to sensory or motor disabilities.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

cognitive laboratory,Shalvata MHC

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Sweetening Agents

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ziv Carmel, MD

  MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 30, 2009

Record last verified: 2009-12

Locations

IL (1)