Nitrous Oxide as Treatment for Major Depression - a Pilot Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | December 2016 |
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.
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.
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.
treatment-resistant major depression, defined as failure of at least 2 antidepressants in
the current depressive episode and 3 lifetime medication failures.
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)
We found this trial at
1
site
Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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