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NCT02757521
Nitrous TRD Bipolar Depression
EARLY_PHASE1 trial testing Nitrous Oxide in Treatment- Resistant Bipolar Disorder in 1 participant. Terminated before completion.
6 December 2016
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 25 March 2016 |
| Primary completion | 6 December 2016 |
| Estimated completion | 6 December 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nitrous Oxide (NITROUS OXIDE) — full drug profile →
- Placebo
Conditions studied
- Treatment- Resistant Bipolar Disorder — all drugs for Treatment- Resistant Bipolar Disorder →
- Bipolar Disorder — all drugs for Bipolar Disorder →
- Bipolar Depressive Disorder — all drugs for Bipolar Depressive Disorder →
Sponsor
Washington University School of Medicine
Who can join
Adults 18 to 75, any sex, with Treatment- Resistant Bipolar Disorder or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (3 terms — click to expand)
| Reaction | System | Placebo | Nitrous Oxide |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Worsened Anxiety | Psychiatric disorders | — | — |
| Feeling more cold mostly in feet | General disorders | — | — |
Data from ClinicalTrials.gov NCT02757521 adverse events section.
Sponsor's own description
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status.
Henter ID, Park LT, Zarate CA. · · 2021 · cited 104× · PMID 33904154 · DOI 10.1007/s40263-021-00816-x -
Psychopharmacology and Experimental Therapeutics for Bipolar Depression.
Jha MK, Murrough JW. · · 2019 · cited 1× · PMID 32047368 · DOI 10.1176/appi.focus.20190009
Verify or expand the search:
- PubMed search for NCT02757521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nitrous Oxide
Trials testing the same drug.
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- NCT04378426 — Nitrous Oxide for PTSD · Phase 2 · terminated
- NCT04884893 — Effect of Nitrous Oxide on EEG · Phase 1 · completed
Other Washington University School of Medicine trials
Trials by the same sponsor.
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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 NCT02757521 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 5 July 2019
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/NCT02757521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing