Nitrous TRD Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Nitrous Oxide - A Novel Therapy for Treatment-Resistant Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02757521
• Other study ID #: 201509128
• Status: Terminated
• Phase: Early Phase 1
• Start date: March 25, 2016
• Est. completion date: December 6, 2016

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depressive Disorder
• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease
• Treatment- Resistant Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	PPD, Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Profile of Mood States (POMS) Short Form to Assess for Rapid/Instantaneous Changes in Mood/Affect		up to 1 week
Other	Quick Inventory of Depressive Symptomatology- Self Report (QIDS -SR) Patient-rated Depression Measure		up to 1 week
Other	Clinician Administered Dissociative States Scale (CADSS) for Emergence of Disassociation		up to 1week
Other	Brief Psychiatric Rating Scale (BPRS) to Assess Psychotic or Hallucinogenic Behavior		up to 1 week
Other	Scale for Suicidal Ideation (SSI) to Assesses for Emergence of Suicidal Thinking		up to 1 week
Primary	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	Hamilton Depression Rating Scale-17 Item (Ham-D17)		up to1week
Secondary	Young Mania Rating Scale (YMRS) to Assess Emergence of Mania/Hypomania	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)	up to 1 week