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NCT03136263
Oxytocin and Cognitive Control in Adult ADHD
EARLY_PHASE1 trial testing Oxytocin nasal spray in Attention Deficit/Hyperactivity Disorder in 24 participants. Completed in 5 November 2020.
5 November 2020
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 14 December 2017 |
| Primary completion | 5 November 2020 |
| Estimated completion | 5 November 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oxytocin nasal spray — full drug profile →
- Placebo nasal spray — full drug profile →
Conditions studied
- Attention Deficit/Hyperactivity Disorder — all drugs for Attention Deficit/Hyperactivity Disorder →
Sponsor
Massachusetts General Hospital
Who can join
Adults 18 to 55, male only, with Attention Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03136263
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Related trials
Other trials of Oxytocin nasal spray
Trials testing the same drug.
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- NCT06881810 — Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment · Phase 2 · recruiting
- NCT06332066 — Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness · Phase 1 · unknown
Other recruiting trials for Attention Deficit/Hyperactivity Disorder
Currently open trials in the same condition.
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- NCT05279313 — A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder. · Phase 3 · active not recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
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- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03136263 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 3 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03136263.
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