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Brain Dopamine Function in Adults With ADHD (Brookhaven)

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Experimental: methylphenidate treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00580814
20054659

Details and patient eligibility

About

The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.

Enrollment

75 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Must give informed consent
  • Must be between the ages of 18 and 45 years old.
  • Must have a confirmed diagnosis of ADHD
  • Must have scored on a rating scale that indicate a significant level of symptom severity.
  • Must have a childhood history of ADHD must be documented using established test criteria.
  • Must have had no previous medication treatment for ADHD except for a short term treatment period of less than three months, which should have occurred at least six months prior to the study.
  • Must have an interest in receiving long-term medication treatment for ADHD.

Exclusion criteria

  • Must not test positive for psychoactive drugs during a urine drug screen.
  • Must not be pregnant.
  • Must not be breastfeeding.
  • Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
  • Must have no past or present history of a psychiatric disorder except ADHD.
  • Must have no medical illness that may affect brain function.
  • Must not have taken medication that may affect brain function.
  • Must not have had head trauma with loss of consciousness (> 30 minutes).
  • Must not have significant anxiety or depression as determined by an established test.
  • Must have no history of a significant learning disability.
  • Must have no history of cardiovascular or endocrinological disease.
  • Must have no history of coagulation disorder.
  • Must have no history of sensitivity to lidocaine and/or prilocaine.
  • Must have no history of claustrophobia.
  • Contraindication to MRI environment (presence of any implanted metallic objects such as cardiac/neural pacemakers, defibrillators, aneurysm clips, certain heart valves, spinal nerve stimulators, artificial joints/limbs, shrapnel/bullets, metal fragments in their eyes, cochlear implants, hearing aids, dental implants).
  • Must have no history of glaucoma.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

methylphenidate
Experimental group
Description:
intervention is methylphenidate once daily for 12 months, doses individually titrated
Treatment:
Drug: Experimental: methylphenidate treatment
No medication
No Intervention group
Description:
no methylphenidate treatment for non ADHD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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