- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136263
Oxytocin and Cognitive Control in Adult ADHD
November 30, 2022 updated by: Franziska Plessow, Massachusetts General Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug order: Oxytocin - placebo
|
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
|
Experimental: Drug order: Placebo - oxytocin
|
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
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
Time Frame: 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)
|
First and second main study visits (1-4 weeks apart)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AX-CPT
Time Frame: 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)
|
First and second main study visits (1-4 weeks apart)
|
Category switch task
Time Frame: 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)
|
First and second main study visits (1-4 weeks apart)
|
Global/local task
Time Frame: 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)
|
First and second main study visits (1-4 weeks apart)
|
Simon task
Time Frame: 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)
|
First and second main study visits (1-4 weeks apart)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Franziska Plessow, Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
December 1, 2022
Last Update Submitted That Met QC Criteria
November 30, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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