Oxytocin and Cognitive Control in Adult ADHD

• Status: Completed
• Trial end date: 2020-11-05
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Oxytocin

Criteria

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