Depressive Disorder, Major Clinical Trial
— NARSADOfficial title:
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Verified date | March 2022 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 18, 2020 |
Est. primary completion date | February 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria 1. Adults 18-75 years of age; 2. Current diagnosis of unipolar major depressive disorder (MDD) without psychosis as confirmed by structured clinical interview for DSM-IV disorders; 3. A score of >= 9 on the Montgomery-Åsberg Depression Rating Scale (MADRS); 4. 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; 5. Good command of the English language. Exclusion Criteria 1. Meets criteria for any DSM-IV diagnosis for schizophrenia, bipolar, schizoaffective, obsessive-compulsive, personality, or panic disorders; 2. Any recent (within past 12 months) history of substance dependence or abuse (except tobacco), determined by reported history or urine drug screen; 3. Ability to become pregnant and not using effective contraception; 4. Contraindication against the use of nitrous oxide: 1. Pneumothorax 2. Bowel obstruction 3. Middle ear occlusion 4. Elevated intracranial pressure 5. Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12 6. Pregnant patients 7. Breastfeeding women 5. Inability to provide informed consent; 6. Any other factor that in the investigators' judgment may affect patient safety or compliance |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Brain & Behavior Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items | Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items. The HAMD-21 is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score as the total score on the first 17 answers. Scale: 0=absent, 4=worst level possible) the scores on the individual items are summed. Changes will be based on measurements obtained at baseline, approximately 2 hours after inhalation, and approximately 24 hours after inhalation. Changes are based on subtracti on of baseline score. | 2 and 24 hours after inhalation |
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