Clinical trial NCT03136263: Oxytocin and Cognitive Control in Adult ADHD
Official title: Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention
Attention deficit/hyperactivity disorder
Cognitive control
Executive control
Executive functions
Impulse control
Impulsivity
Oxytocin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Stop-signal task
timeFrame: First and second main study visits (1-4 weeks apart)
Secondary outcomes:
measure: AX-CPT
timeFrame: First and second main study visits (1-4 weeks apart)
measure: Category switch task
timeFrame: First and second main study visits (1-4 weeks apart)
measure: Global/local task
timeFrame: First and second main study visits (1-4 weeks apart)
measure: Simon task
timeFrame: First and second main study visits (1-4 weeks apart)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References: