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NCT03136263 · ClinicalTrials.gov registry record · Early Phase 1

Oxytocin and Cognitive Control in Adult ADHD

A Early Phase 1 study of Attention Deficit/Hyperactivity Disorder, sponsored by Massachusetts General Hospital.

Completed
Registry status
Early Phase 1
Development phase
24
Enrollment target
1
Study location

NCT03136263 is a Early Phase 1 study of Attention Deficit/Hyperactivity Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 24 participants, below the 298-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03136263, a Early Phase 1 study of Attention Deficit/Hyperactivity Disorder, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Early Phase 1
Development phase
24 participants
Enrollment target
1
Study location

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 Studied

Attention Deficit/Hyperactivity Disorder

Interventions

  • DRUG Oxytocin nasal spray
  • DRUG Placebo nasal spray

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-12-14
Est. Completion 2020-11-05
Phase Early Phase 1

Sponsor

Massachusetts General Hospital

2,032 total trials

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What the Registry Record Tells You About NCT03136263

The ClinicalTrials.gov registry entry for NCT03136263 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 298-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Attention Deficit/Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Oxytocin nasal spray is the first listed.

NCT03136263 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03136263 about?

NCT03136263 is a clinical study titled "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. Duri...

What is the current status of trial NCT03136263?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2017-12-14. Estimated completion is 2020-11-05.

What conditions does trial NCT03136263 study?

This clinical trial studies the following conditions: Attention Deficit/Hyperactivity Disorder.

What interventions are being tested in trial NCT03136263?

The interventions under investigation include: Oxytocin nasal spray (DRUG), Placebo nasal spray (DRUG).

Who is sponsoring clinical trial NCT03136263?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03136263 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.