Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

NCT01415440 | Completed Results DMC

• 1 other identifier: 6235/7261R
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if patients had been treated with stimulant medications, suggesting that stimulants may reduce the symptoms of ADHD by reversing these volume reductions. In a second and related study, the investigators found that in patients with ADHD, emotional processing was normalized when patients were taking stimulant medications. Both studies point to possible mechanisms by which stimulants are effective; however, a significant limitation of these findings is that they were derived from cross-sectional studies. In this current study, the investigators hope to replicate these treatment effects of stimulants in a prospective, controlled manner. The investigators plan to measure ADHD symptom severity in patients before and after 12-weeks of controlled treatment with either a stimulant medication or placebo while utilizing structural and functional MRI. Combining imaging with a randomized controlled trial will allow us to better assess the effects of stimulants on brain function and structure.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Vyvanse; stimulant medication; ADD

Outcome Measures

Primary Outcomes (1)

• Brain Structure Volume

  Brain structure volume measured in mm\^3

  12 weeks

Study Arms (2)

Psychostimulant

EXPERIMENTAL

30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks

Drug: Lisdexamfetamine

Placebo

PLACEBO COMPARATOR

30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks

Drug: Placebo

Interventions

Lisdexamfetamine DRUG

During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment.

Also known as: Vyvanse

Psychostimulant

Placebo DRUG

Placebo dosing will parallel that of Lisdexamfetamine.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ADHD Participants: Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, any subtype.
• Healthy Control Participants: No current DSM-IV-TR Axis I psychiatric diagnosis.
• All Participants:
• Male or female, 6 - 25 years of age, and in good physical health
• English-speaking

You may not qualify if:

• Current comorbid DSM-IV-TR Axis I psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the examining physician, will contraindicate Lisdexamfetamine treatment or confound safety assessments
• Meets DSM-IV-TR criteria for active substance abuse and/or dependence
• Lifetime history of cocaine or stimulant abuse or dependence
• Actively suicidal
• Children and adolescents: Prior treatment with psychostimulants for longer than 1 month duration and/or treatment with psychostimulants within the past 4 months Adults: Treatment with psychostimulants within the past 12 months.
• Documented allergy or intolerance to Lisdexamfetamine or other stimulant medications.
• Taking other medications with central nervous system effects.
• History of seizure (other than febrile seizure)
• Diagnosis of hyperthyroidism, glaucoma, or other serious medical illness.
• Personal or family history of medical conditions, such as cardiovascular disease, that may interfere with study participation, or for which treatment with Lisdexamfetamine may pose a risk
• Pregnant or lactating
• MRI contraindications such as pacemaker, braces, etc.
• Full scale intelligence quotient (FSIQ) less than 70

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Shire: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Wang Y, Kessel E, Lee S, Hong S, Raffanello E, Hulvershorn LA, Margolis A, Peterson BS, Posner J. Causal effects of psychostimulants on neural connectivity: a mechanistic, randomized clinical trial. J Child Psychol Psychiatry. 2022 Nov;63(11):1381-1391. doi: 10.1111/jcpp.13585. Epub 2022 Feb 9.

  PMID: 35141898 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Jonathan Posner, MD
• Organization: NYSPI

jonathan.posner@nyspi.columbia.edu

6467745735

Study Officials

• Jonathan Posner, M.D

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Model Details: Two treatment arms plus sample of healthy controls, who were assessed at one time point

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 2, 2022
• Results First Posted: September 11, 2019

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)