Oxytocin and Cognitive Control in Adult ADHD
Primary Purpose
Attention Deficit/Hyperactivity Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo nasal spray
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit/Hyperactivity Disorder focused on measuring Attention, Attention deficit/hyperactivity disorder, Cognitive control, Executive control, Executive functions, Impulse control, Impulsivity, Oxytocin
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Drug order: Oxytocin - placebo
Drug order: Placebo - oxytocin
Arm Description
Outcomes
Primary Outcome Measures
Stop-signal task
Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)
Secondary Outcome Measures
AX-CPT
Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses)
Category switch task
Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect)
Global/local task
Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect)
Simon task
Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect)
Full Information
NCT ID
NCT03136263
First Posted
April 26, 2017
Last Updated
November 30, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03136263
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
Attention, Attention deficit/hyperactivity disorder, Cognitive control, Executive control, Executive functions, Impulse control, Impulsivity, Oxytocin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug order: Oxytocin - placebo
Arm Type
Experimental
Arm Title
Drug order: Placebo - oxytocin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Intervention Description
Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Primary Outcome Measure Information:
Title
Stop-signal task
Description
Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)
Time Frame
First and second main study visits (1-4 weeks apart)
Secondary Outcome Measure Information:
Title
AX-CPT
Description
Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses)
Time Frame
First and second main study visits (1-4 weeks apart)
Title
Category switch task
Description
Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect)
Time Frame
First and second main study visits (1-4 weeks apart)
Title
Global/local task
Description
Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect)
Time Frame
First and second main study visits (1-4 weeks apart)
Title
Simon task
Description
Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect)
Time Frame
First and second main study visits (1-4 weeks apart)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franziska Plessow, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Oxytocin and Cognitive Control in Adult ADHD
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