Clinical trial

Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder

Name

2017P000123

Description

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 arms

Trial start

2017-12-14

Estimated PCD

2020-11-05

Trial end

2020-11-05

Status

Completed

Phase

Early phase I

Treatment

Oxytocin nasal spray

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

Arms:

Drug order: Oxytocin - placebo, Drug order: Placebo - oxytocin

Placebo nasal spray

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

Arms:

Drug order: Oxytocin - placebo, Drug order: Placebo - oxytocin

Size

Primary endpoint

Stop-signal task

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2024-05-03

1 organization

2 products

1 indication

Organization

Massachusetts General Hospital

Product

Oxytocin

Indication

ADHD

Product

Placebo