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Nitrous Oxide as Treatment for Major Depression - a Pilot Study

Primary Purpose

Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

N2O/Placebo

Placebo/N2O

Arm Description

First session: Nitrous oxide Second session: placebo

First session: Placebo Second session: Nitrous Oxide

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale HDRS-21
(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

Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR
[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.

Full Information

First Posted
May 13, 2014
Last Updated
January 23, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02139540
Brief Title
Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Official Title
Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
Keywords
Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N2O/Placebo
Arm Type
Other
Arm Description
First session: Nitrous oxide Second session: placebo
Arm Title
Placebo/N2O
Arm Type
Other
Arm Description
First session: Placebo Second session: Nitrous Oxide
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Other Intervention Name(s)
Laughing Gas
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
50% nitrogen [inert]/50% oxygen
Intervention Description
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale HDRS-21
Description
(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.
Time Frame
baseline and 24 hours
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR
Description
[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.
Time Frame
baseline and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 18-65 years of age Major depressive disorder without psychosis with as determined by structured interview using the Mini-International Neuropsychiatric Interview (MINI). (baseline ) HDRS-21 score of >18 Good command of the English language Exclusion Criteria: History of: Bipolar disorder Schizoprenia Schizoaffective disorder Obsessive-compulsive disorder, panic disorder 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) Axis II diagnoses that may interfere with the patient's ability to improve on nitrous oxide Acute medical illness that may pose subject at risk during nitrous oxide administration Active suicidal intention (inability to contract for safety) Active psychotic symptoms Patients with significant pulmonary disease and/or requiring supplemental oxygen 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 Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months Current electro-convulsive therapy treatment Any active suicidal ideation, intention, or planning (clinical assessment of suicidality will be used)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Nagele, MD, MSc
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Nitrous Oxide as Treatment for Major Depression - a Pilot Study

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