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Trial Outcomes & Findings for Role of Mirtazapine in Ameliorating Sleep Disordered Breathing (NCT NCT04799782)

NCT ID: NCT04799782

Last Updated: 2021-06-15

Results Overview

Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

One Week

Results posted on

2021-06-15

Participant Flow

Participants were recruited to the primary site at John D. Dingell VA Medical Center.

Of 150 available, 18 participants were enrolled. Of the 18 enrolled, 15 started the study protocol. Of the 15 that started the study protocol, 10 completed the study and had their results analyzed.

Participant milestones

Participant milestones
Measure
Placebo->Mirtazapine
Participants first received a placebo taken once daily for one week. After a washout period of one week, the participants then received mirtazapine taken once daily (15 mg) for one week.
Mirtazapine->Placebo
Participants first received mirtazapine taken once daily (15 mg) for one week. After a washout period of one week, the participants then received a placebo taken once daily for one week.
First Intervention
STARTED
8
7
First Intervention
COMPLETED
8
7
First Intervention
NOT COMPLETED
0
0
Washout
STARTED
8
7
Washout
COMPLETED
6
4
Washout
NOT COMPLETED
2
3
Second Intervention
STARTED
6
4
Second Intervention
COMPLETED
6
4
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo->Mirtazapine
Participants first received a placebo taken once daily for one week. After a washout period of one week, the participants then received mirtazapine taken once daily (15 mg) for one week.
Mirtazapine->Placebo
Participants first received mirtazapine taken once daily (15 mg) for one week. After a washout period of one week, the participants then received a placebo taken once daily for one week.
Washout
Physician Decision
2
0
Washout
Withdrawal by Subject
0
2
Washout
Lost to Follow-up
0
1

Baseline Characteristics

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=15 Participants
Participants who were randomized to receive either Mirtazapine (15 mg) or Placebo tablet
Age, Continuous
48.5 years
STANDARD_DEVIATION 12.4 • n=93 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
Sex: Female, Male
Male
15 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=93 Participants
Race (NIH/OMB)
White
8 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants

PRIMARY outcome

Timeframe: One Week

Population: Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis.

Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.

Outcome measures

Outcome measures
Measure
Mirtazapine
n=10 Participants
The drug will be taken for a one week peroid. Mirtazapine: 15 mg dose before bed-time
Placebo
n=10 Participants
The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time
CO2 Reserve (Delta-PETCO2-AT)
-3.8 mmHg
Standard Deviation 1.2
-2.0 mmHg
Standard Deviation 1.5

SECONDARY outcome

Timeframe: One Week

Population: Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis.

AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI.

Outcome measures

Outcome measures
Measure
Mirtazapine
n=10 Participants
The drug will be taken for a one week peroid. Mirtazapine: 15 mg dose before bed-time
Placebo
n=10 Participants
The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time
AHI (Apnea/Hypopnea Index)
46.4 Events/Hour
Standard Deviation 22.5
47.8 Events/Hour
Standard Deviation 20.6

Adverse Events

Mirtazapine

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Mirtazapine
n=13 participants at risk
The drug will be taken for a one week peroid. Mirtazapine: 15 mg dose before bed-time
Placebo
n=12 participants at risk
The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time
Psychiatric disorders
Suicidal Thoughts
0.00%
0/13 • Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo
Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.
8.3%
1/12 • Number of events 1 • Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo
Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.

Other adverse events

Other adverse events
Measure
Mirtazapine
n=13 participants at risk
The drug will be taken for a one week peroid. Mirtazapine: 15 mg dose before bed-time
Placebo
n=12 participants at risk
The drug will be taken for a one week peroid. Placebo: One placebo pill before bed-time
Musculoskeletal and connective tissue disorders
Muscle Weakness
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo
Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.
0.00%
0/12 • Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo
Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.

Additional Information

Dr. Abdulghani Sankari Principal Investigator

JOHN D DINGELL VA MEDICAL CENTER

Phone: 13135761000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place