Oxytocin and Cognitive Control in Adult ADHD

Description

This is a randomized, double-blind, placebo-controlled crossover study of single-dose intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity disorder (ADHD). Following a screening visit to determine eligibility, subjects will return for two main study visits. During the main study visits, study participants will receive either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by assessments of cognitive control over attention and behavior. Twenty-four participants will be randomized 1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. In an additional neuroimaging substudy, a subset of participants will undergo task-based and resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo administration to investigate the effects of oxytocin on fMRI activation and functional connectivity within the cognitive control network.

Study Start Date

October, 01 2017

Estimated Completion Date

June 2019

Interventions

  • Drug: Oxytocin nasal spray
  • Drug: Placebo nasal spray

Study ID

Massachusetts General Hospital -- 2017P000123

Status

Recruiting

Trial ID

NCT03136263

Study Type

Interventional

Trial Phase

Early Phase 1

Enrollment Quota

24

Sponsor

Massachusetts General Hospital

Inclusion criteria:
  • Male
  • 18-55 years
  • Diagnosis of attention deficit/hyperactivity disorder Exclusion criteria:
  • History of cardiovascular disease (e.g., hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
  • History of diabetes mellitus
  • Untreated thyroid disease
  • Hematocrit below the normal range
  • Tobacco use
  • Any other significant illness that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk
  • Gender

    Male

    Ages

    18 Years to 55 Years

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None

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