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NCT02757521

Nitrous TRD Bipolar Depression

Terminated EARLY_PHASE1 Results posted Last updated 5 July 2019
What this trial tests

EARLY_PHASE1 trial testing Nitrous Oxide in Treatment- Resistant Bipolar Disorder in 1 participant. Terminated before completion.

Timeline
25 March 2016
Primary endpoint
6 December 2016
6 December 2016

Quick facts

Lead sponsorWashington University School of Medicine
PhaseEARLY_PHASE1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1
Start date25 March 2016
Primary completion6 December 2016
Estimated completion6 December 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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.

Placebo
Serious: 0/1 (0%)
Deaths: 0/1
Nitrous Oxide
Serious: 0/1 (0%)
Deaths: 0
Other adverse events (3 terms — click to expand)

ReactionSystemPlaceboNitrous Oxide
HeadacheNervous system disorders
Worsened AnxietyPsychiatric disorders
Feeling more cold mostly in feetGeneral 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):

  1. 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
  2. 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:

Other trials of Nitrous Oxide

Trials testing the same drug.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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