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Trial record 54 of 2546 for:    depression AND Major Depression | "Depression"

Nitrous Oxide as Treatment for Major Depression - a Pilot Study

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ClinicalTrials.gov Identifier: NCT02139540
Recruitment Status : Unknown
Verified January 2016 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : January 14, 2016
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Study Start Date : November 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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 HDRS-21 (21-point Hamilton Depression Rating Scale) [ Time Frame: baseline and 24 hours ]

Secondary Outcome Measures :
  1. Change in QIDS -SR [Quick Inventory of Depressive Symptomatology - Self Report] [ Time Frame: baseline and 24 hours ]
  2. Clinical Depression Endpoints [ Time Frame: 24 hours ]
    Rates of response (HRDS<50% compared to baseline) and remission (HRDS ≤ 7 points) according to the HRDS-21

  3. Change in Plasma Total Homocysteine [ Time Frame: baseline and 24hours ]

Other Outcome Measures:
  1. Number of Adverse Events [ Time Frame: 24 hours ]
    • Cardiovascular AEs, such as hyper- and hypotension, tachy-/bradycardia
    • Respiratory AEs, such as respiratory depression and desaturation
    • Psychiatric AEs, such as psychotic symptoms or suicidal ideation



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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
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Peter Nagele, MD, MSc Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02139540     History of Changes
Other Study ID Numbers: 201204023
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Washington University School of Medicine:
Treatment

Additional relevant MeSH terms:
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