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Nitrous TRD Bipolar Depression

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ClinicalTrials.gov Identifier: NCT02757521
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Stanley Medical Research Institute
PPD
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week.

Condition or disease Intervention/treatment Phase
Treatment- Resistant Bipolar Disorder Bipolar Disorder Bipolar Depressive Disorder Drug: Nitrous Oxide Drug: Placebo Early Phase 1

Detailed Description:
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week. Post-treatment assessments follow each inhalation treatment and are conducted 1 week and 2 weeks following the final inhalation treatment. Patients are then randomized again into the Second Stage of the study, involving the same treatment and post-treatment schedule as the First Stage detailed above.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nitrous Oxide - A Novel Therapy for Treatment-Resistant Bipolar Depression
Actual Study Start Date : November 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Drug: Placebo
50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)

Experimental: Nitrous Oxide
50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Drug: Nitrous Oxide
50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Other Name: Laughing Gas




Primary Outcome Measures :
  1. Change in MADRS (Montgomery Asberg Depression Rating Scale) [ Time Frame: up to 1 week ]
    Change in depressive symptoms on MADRS scale between baseline and day 7 follow up


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale-17 item (Ham-D17) [ Time Frame: up to1week ]
  2. Young Mania Rating Scale (YMRS) to assess emergence of mania/hypomania [ Time Frame: up to 1 week ]
    Young Mania Rating Scale (YMRS) to assess emergence of mania/hypomania (patients with YMRS scores > 12 will be removed from the trial and recommended for follow up treatment per Psychiatry P.I., i.e., nitrous oxide treatments discontinued)


Other Outcome Measures:
  1. Profile of Mood States (POMS) short form to assess for rapid/instantaneous changes in mood/affect [ Time Frame: up to 1 week ]
  2. Quick Inventory of Depressive Symptomatology- Self Report (QIDS -SR) patient-rated depression measure [ Time Frame: up to 1 week ]
  3. Clinician Administered Dissociative States Scale (CADSS) for emergence of disassociation [ Time Frame: up to 1week ]
  4. Brief Psychiatric Rating Scale (BPRS) to assess psychotic or hallucinogenic behavior [ Time Frame: up to 1 week ]
  5. Scale for Suicidal Ideation (SSI) to assesses for emergence of suicidal thinking [ Time Frame: up to 1 week ]


Information from the National Library of Medicine

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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:

  • Adults 18-65 years of age
  • Treatment-resistant bipolar depressive disorder without psychosis and a MADRS baseline score of >20. All patients must have history of being on a serum-verified (at time of entry into study) mood stabilizer [lithium at 0.5-1.2mEq/L; or valproic acid, 50-125mcg/ml] for 4 weeks prior to entry into the study and remain on this mood stabilizer during the course of the trial. Further, subjects will have failed two adequate dose/duration antidepressant courses in their lifetime, including one in the current depressive episode (verified by Antidepressant Treatment History Form).
  • Good command of the English language

Exclusion Criteria:

  • Schizophrenia
  • Schizoaffective disorder
  • Obsessive-compulsive disorder or panic disorder
  • Active or recent substance abuse or dependence (in remission at least 1 year prior to the study; exception = nicotine use disorders)
  • A diagnosis of personality disorder that may interfere with the patient's ability to improve on nitrous oxide as determined by study investigator
  • Acute medical illness that may pose subject at risk during nitrous oxide administration (neurological disorders or medical disorders including dementia, stroke, encephalopathy, Parkinson's Disease, brain tumors, multiple sclerosis, seizure disorder, severe cardiac disease, any disease known to affect drug metabolism and excretion, i.e. renal or liver disease) per P.I. discretion
  • 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); current electro-convulsive therapy treatment

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): NCT02757521


Contacts
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Contact: Britt Gott 3143622463 gottb@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer Anger    314-747-7348    angerje@psychiatry.wustl.edu   
Principal Investigator: Peter Nagele, MD         
Sponsors and Collaborators
Washington University School of Medicine
Stanley Medical Research Institute
PPD
Investigators
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Principal Investigator: Ben Palanca, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02757521     History of Changes
Other Study ID Numbers: 201509128
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

Keywords provided by Washington University School of Medicine:
Bipolar Depressive Disorder
Treatment- Resistant Bipolar Disorder
Nitrous Oxide

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Disease
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related 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