NCT03136263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

April 26, 2017

Last Update Submit

May 1, 2024

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

AttentionAttention deficit/hyperactivity disorderCognitive controlExecutive controlExecutive functionsImpulse controlImpulsivityOxytocin

Outcome Measures

Primary Outcomes (1)

  • Stop-signal task

    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 Outcomes (4)

  • AX-CPT

    First and second main study visits (1-4 weeks apart)

  • Category switch task

    First and second main study visits (1-4 weeks apart)

  • Global/local task

    First and second main study visits (1-4 weeks apart)

  • Simon task

    First and second main study visits (1-4 weeks apart)

Study Arms (2)

Drug order: Oxytocin - placebo

EXPERIMENTAL
Drug: Oxytocin nasal sprayDrug: Placebo nasal spray

Drug order: Placebo - oxytocin

EXPERIMENTAL
Drug: Oxytocin nasal sprayDrug: Placebo nasal spray

Interventions

Oxytocin nasal sprayDRUG

Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)

Drug order: Oxytocin - placeboDrug order: Placebo - oxytocin
Placebo nasal sprayDRUG

Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)

Drug order: Oxytocin - placeboDrug order: Placebo - oxytocin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • years
  • Diagnosis of attention deficit/hyperactivity disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityImpulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Elizabeth A Lawson, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 2, 2017

Study Start

December 14, 2017

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)