Oxytocin and Cognitive Control in Adult ADHD

Early Phase 1

Completed

• Conditions: Attention Deficit/Hyperactivity Disorder
• Interventions: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

• Registration Number: NCT03136263
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Study Start: 2017-12-14
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drug order: Oxytocin - placebo	Placebo nasal spray	-
Drug order: Placebo - oxytocin	Oxytocin nasal spray	-
Drug order: Placebo - oxytocin	Placebo nasal spray	-
Drug order: Oxytocin - placebo	Oxytocin nasal spray	-

Primary Outcome Measures

Name	Time	Method
Stop-signal task	First and second main study visits (1-4 weeks apart)	Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)

Secondary Outcome Measures

Name	Time	Method
AX-CPT	First and second main study visits (1-4 weeks apart)	Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses)
Category switch task	First and second main study visits (1-4 weeks apart)	Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect)
Global/local task	First and second main study visits (1-4 weeks apart)	Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect)
Simon task	First and second main study visits (1-4 weeks apart)	Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States