Status:
TERMINATED
Nitrous TRD Bipolar Depression
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Stanley Medical Research Institute
PPD Development, LP
Conditions:
Treatment- Resistant Bipolar Disorder
Bipolar Disorder
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 life...
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 life...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02757521
Start Date
March 25 2016
End Date
December 6 2016
Last Update
July 5 2019
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110