Overview

This trial is active, not recruiting.

Conditions depression, major depressive disorder
Treatments nitrous oxide, placebo
Phase phase 2
Sponsor Washington University School of Medicine
Start date November 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT02139540, 201204023

Summary

Major depressive disorder (MDD) is a global medical problem with significant shortcomings in current therapy. Chief among these is the delay between initiation of pharmacologic therapy and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and perhaps without the need for intravenous access and anesthesia personnel. Therefore, we propose conducting a pilot randomized placebo controlled double-blind crossover study in which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for a period of one hour in addition to standard medical therapy. Depression severity will be assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the Hamilton depression rating scale.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
First session: Nitrous oxide Second session: placebo
nitrous oxide Laughing Gas
Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.
placebo 50% nitrogen [inert]/50% oxygen
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
(Other)
First session: Placebo Second session: Nitrous Oxide
nitrous oxide Laughing Gas
Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.
placebo 50% nitrogen [inert]/50% oxygen
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup

Primary Outcomes

Measure
Change in HDRS-21 (21-point Hamilton Depression Rating Scale)
time frame: baseline and 24 hours

Secondary Outcomes

Measure
Change in QIDS -SR [Quick Inventory of Depressive Symptomatology - Self Report]
time frame: baseline and 24 hours
Clinical Depression Endpoints
time frame: 24 hours
Change in Plasma Total Homocysteine
time frame: baseline and 24hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Adults 18-65 years of age 2. Major depressive disorder without psychosis with as determined by structured interview using the Mini-International Neuropsychiatric Interview (MINI). (baseline ) 3. HDRS-21 score of >18 4. Good command of the English language Exclusion Criteria: History of: 1. Bipolar disorder 2. Schizoprenia 3. Schizoaffective disorder 4. Obsessive-compulsive disorder, panic disorder 5. Substance abuse or dependence (except for remote substance abuse or dependence with remission at least 1 year prior to the study and except for nicotine use disorders) 6. Axis II diagnoses that may interfere with the patient's ability to improve on nitrous oxide 7. Acute medical illness that may pose subject at risk during nitrous oxide administration 8. Active suicidal intention (inability to contract for safety) 9. Active psychotic symptoms 10. Patients with significant pulmonary disease and/or requiring supplemental oxygen 11. 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 12. Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months 13. Current electro-convulsive therapy treatment 14. Any active suicidal ideation, intention, or planning (clinical assessment of suicidality will be used)

Additional Information

Official title Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Principal investigator Peter Nagele, MD, MSc
Description We will study 20 patients with non-treatment resistant major depression and 20 patients with treatment-resistant major depression, defined as failure of at least 2 antidepressants in the current depressive episode and 3 lifetime medication failures.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.