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Completed

NCT Number: NCT03136263

Oxytocin and Cognitive Control in Adult ADHD

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.

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Key information

Conditions

Attention Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Impulsive Behavior Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin nasal spray

Drug

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

Placebo nasal spray

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 2, 2017
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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