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Nitrous TRD Bipolar Depression

Primary Purpose

Treatment- Resistant Bipolar Disorder, Bipolar Disorder, Bipolar Depressive Disorder

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nitrous Oxide

Placebo

About this trial

This is an interventional treatment trial for Treatment- Resistant Bipolar Disorder focused on measuring Bipolar Depressive Disorder, Treatment- Resistant Bipolar Disorder, Nitrous Oxide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nitrous Oxide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in MADRS (Montgomery Asberg Depression Rating Scale)

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

Secondary Outcome Measures

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

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)

Full Information

NCT ID

NCT02757521

First Posted

April 14, 2016

Last Updated

April 10, 2019

Sponsor

Washington University School of Medicine

Collaborators

Stanley Medical Research Institute, PPD

1. Study Identification

Unique Protocol Identification Number

NCT02757521

Brief Title

Nitrous TRD Bipolar Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Study sponsor ended trial due to low recruitment

Study Start Date

March 25, 2016 (Actual)

Primary Completion Date

December 6, 2016 (Actual)

Study Completion Date

December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Stanley Medical Research Institute, PPD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment- Resistant Bipolar Disorder, Bipolar Disorder, Bipolar Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Nitrous Oxide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nitrous Oxide

Other Intervention Name(s)

Laughing Gas

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in MADRS (Montgomery Asberg Depression Rating Scale)

Description

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

Time Frame

up to 1 week

Secondary Outcome Measure Information:

Title

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

Time Frame

up to1week

Title

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

Description

Time Frame

up to 1 week

Other Pre-specified Outcome Measures:

Title

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

Time Frame

up to 1 week

Title

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

Time Frame

up to 1 week

Title

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

Time Frame

up to 1week

Title

Brief Psychiatric Rating Scale (BPRS) to Assess Psychotic or Hallucinogenic Behavior

Time Frame

up to 1 week

Title

Scale for Suicidal Ideation (SSI) to Assesses for Emergence of Suicidal Thinking

Time Frame

up to 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ben Palanca, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

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Nitrous TRD Bipolar Depression

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