Oxytocin and Cognitive Control in Adult ADHD

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136263
• Other study ID #: 2017P000123
• Status: Completed
• Phase: Early Phase 1
• Start date: December 14, 2017
• Est. completion date: November 5, 2020

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Oxytocin nasal spray
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
• Placebo nasal spray
Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)