Attention Deficit/Hyperactivity Disorder
Conditions
Keywords
Attention, Attention deficit/hyperactivity disorder, Cognitive control, Executive control, Executive functions, Impulse control, Impulsivity, Oxytocin
Brief summary
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.
Interventions
DRUGOxytocin nasal spray
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
DRUGPlacebo nasal spray
Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stop-signal task | First and second main study visits (1-4 weeks apart) | Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global/local task | First and second main study visits (1-4 weeks apart) | Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect) |
| Simon task | First and second main study visits (1-4 weeks apart) | Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect) |
| AX-CPT | First and second main study visits (1-4 weeks apart) | Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses) |
| Category switch task | First and second main study visits (1-4 weeks apart) | Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect) |
Countries
United States
Outcome results
None listed