Oxytocin and Cognitive Control in Adult ADHD

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03136263
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit/Hyperactivity Disorder	Drug: Oxytocin nasal spray; Drug: Placebo nasal spray	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder
• Actual Study Start Date: Dec 14, 2017
• Actual Primary Completion Date: Nov 5, 2020
• Actual Study Completion Date: Nov 5, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Franziska Plessow, Ph.D., Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Franziska Plessow, Assistant Investigator/Assistant Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03136263
• Other Study ID Numbers: 2017P000123
• First Posted: May 2, 2017
• Last Update Posted: Nov 4, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Franziska Plessow, Assistant Investigator/Assistant Professor of Medicine, Massachusetts General Hospital: Attention; Attention deficit/hyperactivity disorder; Cognitive control; Executive control; Executive functions; Impulse control; Impulsivity; Oxytocin
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Oxytocin

Study Results

No Results Posted as of Nov 4, 2021