RECRUITING

Antidepressant Effects of Nitrous Oxide

Talk to us

Conditions

Major Depressive DisorderTreatment Resistant DepressionDepressionAntidepressantNitrous Oxide

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the acute and sustained antidepressant effects of nitrous oxide in people with major depressive disorder; and further evaluate these effects by identifying the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.

Official Title

Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder

Quick Facts

Study Start:2021-06-30
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05357040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult (≥18 years, both sexes)
  2. 2. DSM-5 criteria for MDD without psychosis, as determined using a structured clinical interview \[Mini International Neuropsychiatric Interview\], MDD, defined by a pre-treatment score \>16 on the HDRS-21 scale and meeting DSM-5 for MDD
  1. 1. A current or past history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  2. 2. Current obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses
  3. 3. Active suicidal intention, as determined by clinical interview assessment tool (Sheehan-STS) and clinical examination
  4. 4. Active or recent (\<12 months) substance use disorder; excluding nicotine
  5. 5. Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
  6. 6. Ongoing treatment with ECT
  7. 7. Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
  8. 8. Pregnancy or breastfeeding
  9. 9. Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).

Contacts and Locations

Study Contact

Frank Brown Jr
CONTACT
773-834-5778
fbrown@dacc.uchicago.edu

Principal Investigator

Peter Nagele, MD, MSc
PRINCIPAL_INVESTIGATOR
University of Chicago, Department of Anesthesia and Critical Care
Paul Myles, MD
PRINCIPAL_INVESTIGATOR
The Alfred Hospital, Department of Anesthesiology and Perioperative Medicine

Study Locations (Sites)

University of Chicago Medicine
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Peter Nagele, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Chicago, Department of Anesthesia and Critical Care
  • Paul Myles, MD, PRINCIPAL_INVESTIGATOR, The Alfred Hospital, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-30
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-06-30
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Antidepressant
  • Nitrous Oxide

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Treatment Resistant Depression