Oxytocin and Cognitive Control in Adult ADHD

Purpose

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, participants 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.

Condition

  • Attention Deficit/Hyperactivity Disorder

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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 or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk - Excluded at the investigator's clinical judgement of ADHD symptom severity

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Drug order: Oxytocin - placebo
  • Drug: Oxytocin nasal spray
    Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
  • Drug: Placebo nasal spray
    Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Experimental
Drug order: Placebo - oxytocin
  • Drug: Oxytocin nasal spray
    Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
  • Drug: Placebo nasal spray
    Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact