Trials / Terminated
TerminatedNCT02757521
Nitrous TRD Bipolar Depression
Nitrous Oxide - A Novel Therapy for Treatment-Resistant Bipolar Depression
- Status
- Terminated
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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. Post-treatment assessments follow each inhalation treatment and are conducted 1 week and 2 weeks following the final inhalation treatment. Patients are then randomized again into the Second Stage of the study, involving the same treatment and post-treatment schedule as the First Stage detailed above.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nitrous Oxide | 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) |
| DRUG | Placebo | 50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) |
Timeline
- Start date
- 2016-03-25
- Primary completion
- 2016-12-06
- Completion
- 2016-12-06
- First posted
- 2016-05-02
- Last updated
- 2019-07-05
- Results posted
- 2019-07-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02757521. Inclusion in this directory is not an endorsement.