Trial Outcomes & Findings for Nitrous TRD Bipolar Depression (NCT NCT02757521)

Results Overview

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

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

1 participants

Primary outcome timeframe

up to 1 week

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 50% nitrogen {inert}/ 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)	Nitrous Oxide 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 50% nitrogen {inert}/ 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)	Nitrous Oxide 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Overall Study Adverse Event	1	0

Baseline Characteristics

Nitrous TRD Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants 50% nitrogen {inert}/ 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)	Nitrous Oxide 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants	—	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 week

Population: Difficulty with recruitment caused study sponsor to end trial after designated award length; no analysis done

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to1week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 week

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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 week

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nitrous Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=1 participants at risk 50% nitrogen {inert}/ 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)	Nitrous Oxide n=1 participants at risk 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F) Nitrous Oxide: 50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • 2 weeks No participants enrolled in Nitrous Oxide arm	— 0/0 • 2 weeks No participants enrolled in Nitrous Oxide arm
Psychiatric disorders Worsened Anxiety	100.0% 1/1 • Number of events 1 • 2 weeks No participants enrolled in Nitrous Oxide arm	— 0/0 • 2 weeks No participants enrolled in Nitrous Oxide arm
General disorders Feeling more cold mostly in feet	100.0% 1/1 • Number of events 3 • 2 weeks No participants enrolled in Nitrous Oxide arm	— 0/0 • 2 weeks No participants enrolled in Nitrous Oxide arm

Additional Information

Ben J Palanca, MD PhD MSC

Washington University

Phone: 314-286-0132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place