Status:
COMPLETED
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Brain & Behavior Research Foundation
Conditions:
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.
Detailed Description
Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are r...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adults 18-75 years of age;
- Current diagnosis of unipolar major depressive disorder (MDD) without psychosis as confirmed by structured clinical interview for DSM-IV disorders;
- A score of \>= 9 on the Montgomery-Åsberg Depression Rating Scale (MADRS);
- Documented (i.e., chart review) lifetime failure to respond to \>=3 adequate dose/duration antidepressant treatment trials, ≥1 medication failure in the current depressive episode;
- Good command of the English language.
- Exclusion Criteria
- Meets criteria for any DSM-IV diagnosis for schizophrenia, bipolar, schizoaffective, obsessive-compulsive, personality, or panic disorders;
- Any recent (within past 12 months) history of substance dependence or abuse (except tobacco), determined by reported history or urine drug screen;
- Ability to become pregnant and not using effective contraception;
- Contraindication against the use of nitrous oxide:
- Pneumothorax
- Bowel obstruction
- Middle ear occlusion
- Elevated intracranial pressure
- Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
- Pregnant patients
- Breastfeeding women
- Inability to provide informed consent;
- Any other factor that in the investigators' judgment may affect patient safety or compliance
Exclusion
Key Trial Info
Start Date :
November 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03283670
Start Date
November 22 2016
End Date
February 18 2020
Last Update
April 4 2022
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110