Oxytocin and Cognitive Control in Adult ADHD

Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elizabeth A Lawson, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive control; Oxytocin; Attention; Impulsivity; Executive functions; Impulse control; Attention deficit/hyperactivity disorder; Executive control
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2017P000123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No