Nitrous TRD Bipolar Depression

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The Washington University

Status and phase

Terminated
Early Phase 1

Conditions

Bipolar Depressive Disorder
Bipolar Disorder
Treatment- Resistant Bipolar Disorder

Treatments

Drug: Nitrous Oxide
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02757521
201509128

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Treatment:
Drug: Placebo
Nitrous Oxide
Experimental group
Description:
50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Treatment:
Drug: Nitrous Oxide

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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