Nitrous TRD Bipolar Depression

NCT02757521 | Terminated Early Phase 1 Results DMC

• 1 other identifier: 201509128
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment- Resistant Bipolar Disorder; Bipolar Disorder; Bipolar Depressive Disorder

Keywords

Bipolar Depressive Disorder; Treatment- Resistant Bipolar Disorder; Nitrous Oxide

Outcome Measures

Primary Outcomes (1)

• Change in MADRS (Montgomery Asberg Depression Rating Scale)

  Change in depressive symptoms on MADRS scale between baseline and day 7 follow up

  up to 1 week

Secondary Outcomes (2)

• Hamilton Depression Rating Scale-17 Item (Ham-D17)

  up to1week

• Young Mania Rating Scale (YMRS) to Assess Emergence of Mania/Hypomania

  up to 1 week

Other Outcomes (5)

• Profile of Mood States (POMS) Short Form to Assess for Rapid/Instantaneous Changes in Mood/Affect

  up to 1 week

• Quick Inventory of Depressive Symptomatology- Self Report (QIDS -SR) Patient-rated Depression Measure

  up to 1 week

• Clinician Administered Dissociative States Scale (CADSS) for Emergence of Disassociation

  up to 1week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)

Drug: Placebo

Nitrous Oxide

EXPERIMENTAL

50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)

Also known as: Laughing Gas

Nitrous Oxide

Placebo DRUG

50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Stanley Medical Research Institute: collaborator
• PPD Development, LP: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Ben J Palanca, MD PhD MSC
• Organization: Washington University

palancab@wustl.edu

314-286-0132

Study Officials

• Ben Palanca, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 2, 2016
• Study Start: March 25, 2016
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

US (1)