Nitrous Oxide as Treatment for Major Depression - a Pilot Study

Depression Clinical Trial

Official title:

Nitrous Oxide as Treatment for Major Depression - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139540
• Other study ID #: 201204023
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• Placebo
50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 24 hours
Secondary	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.	baseline and 24 hours