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Oxytocin and Cognitive Control in Adult ADHD

NCT03136263 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

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)

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Elizabeth A Lawson, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2020-11-05
Completion
2020-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03136263 on ClinicalTrials.gov