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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: Completed Early Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Massachusetts General Hospital.
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 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)
Conditions Studied
Interventions
- DRUG Oxytocin nasal spray
- DRUG Placebo nasal spray
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2020-11-05 |
| Phase | Early Phase 1 |
What the finished NCT03136263 record still lists
NCT03136263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03136263's enrollment target sits among peer trials
24 93rd of 102 higher than 10 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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