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Nitrous Oxide as Treatment for Major Depression - a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139540
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Drug: Nitrous Oxide Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Actual Study Start Date : November 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
N2O/Placebo
First session: Nitrous oxide Second session: placebo
Drug: Nitrous Oxide
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.
Other Name: Laughing Gas

Drug: Placebo
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Other Name: 50% nitrogen [inert]/50% oxygen

Placebo/N2O
First session: Placebo Second session: Nitrous Oxide
Drug: Nitrous Oxide
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.
Other Name: Laughing Gas

Drug: Placebo
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Other Name: 50% nitrogen [inert]/50% oxygen




Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale HDRS-21 [ Time Frame: baseline and 24 hours ]
    (21-point Hamilton Depression Rating Scale) Scoring is based on the first 17 items on the 21 point scale. Eight items are scored on a 5-point scale, ranging form 0=not present to 4= severe. Nine are scored from 0-2.


Secondary Outcome Measures :
  1. Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR [ Time Frame: baseline and 24 hours ]
    [Quick Inventory of Depressive Symptomatology - Self Report] An item-by-item severity scale of 0 to 3, with possible total scores ranging from 0 to 84. The items on the scale are added together for a total score. Higher scores mean worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139540


Locations
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United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Peter Nagele, MD, MSc Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02139540    
Other Study ID Numbers: 201204023
First Posted: May 15, 2014    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Washington University School of Medicine:
Treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents