Brain Dopamine Function in Adults With ADHD

NCT ID: NCT00580814

Last Updated: 2024-08-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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methylphenidate

intervention is methylphenidate once daily for 12 months, doses individually titrated

Group Type EXPERIMENTAL

Experimental: methylphenidate treatment

Intervention Type DRUG

subjects received mehtylphenidate treatment for 12 months

No medication

no methylphenidate treatment for non ADHD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: methylphenidate treatment

subjects received mehtylphenidate treatment for 12 months

Intervention Type DRUG

Other Intervention Names

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methylphenidate once daily for 12 months, doses individually titrated for efficacy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Coleen Cunningham

Professor and Chair of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tim Wigal, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

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UCI Child Development Center

Irvine, California, United States

Site Status

Countries

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United States

References

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Wang GJ, Volkow ND, Wigal T, Kollins SH, Newcorn JH, Telang F, Logan J, Jayne M, Wong CT, Han H, Fowler JS, Zhu W, Swanson JM. Long-term stimulant treatment affects brain dopamine transporter level in patients with attention deficit hyperactive disorder. PLoS One. 2013 May 15;8(5):e63023. doi: 10.1371/journal.pone.0063023. Print 2013.

Reference Type BACKGROUND
PMID: 23696790 (View on PubMed)

Volkow, N.d., Wand, G., Kollins., Wigal, T., Newcorn, J., Telang, F., Fowler, J., Solanto, M.V., Logan, J., Ma, Y., Pradham. K., Wong, C., Zhu, W. & Swanson, J.M. Dopamine Reward Pathway Disrupted in Patients with ADHD: Therapeutic Implications, Journal of American Medical Association.

Reference Type RESULT

Other Identifiers

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20054659

Identifier Type: -

Identifier Source: org_study_id

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