Attention Deficit/Hyperactivity DisorderEarly Phase 1NCT03136263
Oxytocin and Cognitive Control in Adult ADHD
A Early Phase 1 study testing Oxytocin nasal spray in people with Attention Deficit/Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 5 Nov 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- 18-55 years
- Diagnosis of attention deficit/hyperactivity disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Oxytocin nasal spray, Placebo nasal spray
- Keywords
- Attention, Attention deficit/hyperactivity disorder, Cognitive control, Executive control, Executive functions, Impulse control, Impulsivity, Oxytocin
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
Placebo nasal sprayDrug
Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| Drug order: Oxytocin - placebo | Experimental | Not described Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
| Drug order: Placebo - oxytocin | Experimental | Not described Receives: Drug: Oxytocin nasal spray; Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop-signal task
Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)
Measured: First and second main study visits (1-4 weeks apart)
Secondary outcomes (4)
AX-CPT
Mean difference in performance on the AX-CPT between the oxytocin and placebo visits (AY and BX responses)
Measured: First and second main study visits (1-4 weeks apart)
Category switch task
Mean difference in performance on the category switch task between the oxytocin and placebo visits (switch costs and target congruency effect)
Measured: First and second main study visits (1-4 weeks apart)
Global/local task
Mean difference in performance on the global/local task between the oxytocin and placebo visits (global precedence effect)
Measured: First and second main study visits (1-4 weeks apart)
Simon task
Mean difference in performance on the Simon task between the oxytocin and placebo visits (Simon effect and Garner effect)
Measured: First and second main study visits (1-4 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start14 Dec 2017
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136263
- Sponsor's protocol ID
- 2017P000123
- Status last verified
- May 2024
- First submitted
- 26 Apr 2017
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03136263
- Acronym / sponsor ID
- 2017P000123
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Attention, Attention deficit/hyperactivity disorder, Cognitive control, Executive control, Executive functions, Impulse control, Impulsivity, Oxytocin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug order: Oxytocin - placebo | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal spray |
| Drug order: Placebo - oxytocin | Experimental | Drug: Oxytocin nasal spray, Drug: Placebo nasal spray |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-55 years
- Diagnosis of attention deficit/hyperactivity disorder
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spraySingle-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) | Drug | Drug order: Oxytocin - placebo, Drug order: Placebo - oxytocin |
| Placebo nasal spraySingle-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) | Drug | Drug order: Oxytocin - placebo, Drug order: Placebo - oxytocin |
Primary outcome
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)
4 secondary outcomes
AX-CPT
Time frame: 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)
Global/local task
Time frame: First and second main study visits (1-4 weeks apart)
Simon task
Time frame: First and second main study visits (1-4 weeks apart)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Lawson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin nasal spray in people with Attention Deficit/Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop-signal task (time frame: First and second main study visits (1-4 weeks apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.