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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug order: Oxytocin - placebo | Experimental |
| |
| Drug order: Placebo - oxytocin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin nasal spray | Drug | Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stop-signal task | Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time) | First and second main study visits (1-4 weeks apart) |
| Measure | Description | Time Frame |
|---|---|---|
| AX-CPT | Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses) | First and second main study visits (1-4 weeks apart) |
| Category switch task | Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Placebo nasal spray | Drug | Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) |
|
| First and second main study visits (1-4 weeks apart) |
| Global/local task | Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect) | First and second main study visits (1-4 weeks apart) |
| Simon task | Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect) | First and second main study visits (1-4 weeks apart) |