Trial Outcomes & Findings for Reducing Suicidal Ideation Through Insomnia Treatment (NCT NCT01689909)

NCT ID: NCT01689909

Last Updated: 2022-02-16

Results Overview

This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: Over 8 weeks of treatment
• Results posted on: 2022-02-16

Participant Flow

Participant milestones

Measure	Zolpidem-CR Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Overall Study STARTED	51	52
Overall Study COMPLETED	51	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Suicidal Ideation Through Insomnia Treatment

Baseline characteristics by cohort

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks	Total n=103 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	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 14.5 • n=5 Participants	41.2 years STANDARD_DEVIATION 12.0 • n=7 Participants	40.5 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	51 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	52 participants n=7 Participants	103 participants n=5 Participants
Scale for Suicide Ideation	12.2 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants	11.8 units on a scale STANDARD_DEVIATION 5.3 • n=7 Participants	12.0 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants
Columbia Suicide Severity Rating Scale (C-SSRS) - suicide ideation scale	1.71 units on a scale STANDARD_DEVIATION 10.3 • n=5 Participants	1.58 units on a scale STANDARD_DEVIATION 10.2 • n=7 Participants	1.64 units on a scale STANDARD_DEVIATION 1.02 • n=5 Participants
Hamilton Rating Scale for Depression -24	28.7 units on a scale STANDARD_DEVIATION 4.7 • n=5 Participants	29.6 units on a scale STANDARD_DEVIATION 7.0 • n=7 Participants	29.1 units on a scale STANDARD_DEVIATION 5.9 • n=5 Participants
Disturbing Dreams Nightmare Severity Index	10.5 units on a scale STANDARD_DEVIATION 8.8 • n=5 Participants	10.2 units on a scale STANDARD_DEVIATION 7.7 • n=7 Participants	10.3 units on a scale STANDARD_DEVIATION 8.2 • n=5 Participants
Insomnia Severity Index	20.6 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	21.1 units on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	20.8 units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants

PRIMARY outcome

Timeframe: Over 8 weeks of treatment

This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Scale for Suicide Ideation Index (SSI)	4.66 units on a scale Standard Error 0.58	5.25 units on a scale Standard Error 0.59

PRIMARY outcome

Timeframe: 8 weeks of treatment

Population: all evaluable randomized participants

The suicide ideation scale of the C-SSRS is rated 0-5, with "0" meaning no suicidal ideation, "1" meaning a wish t be dead, "2" meaning non-specific active suicidal thoughts, "3" meaning active suicidal ideation with any methods but no plan or intent, "4" meaning active suicidal ideation with some intent but no specific plan, and "5" meaning active suicidal ideation with intent and a specific plan

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale	0.5447 units on a scale Standard Error 0.0869	0.8067 units on a scale Standard Error 0.0875

SECONDARY outcome

Timeframe: 8 weeks of treatment

The Dysfunctional Beliefs and Attitudes About Sleep scale has 16 items and is self administered. Each item is scored 0-10. The total score is an average of the scores of the 16 items. Hence the range of the total score is also 0-10, with higher scores indicating greater dysfunctional beliefs about sleep

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Dysfunctional Beliefs and Attitudes About Sleep	6.03 units on a scale Standard Error 0.171	6.07 units on a scale Standard Error 0.171

SECONDARY outcome

Timeframe: 8 weeks of treatment

This self-rated scale has 5 items, with asymmetric weighting of each item. The range of the total score is 0-37, with higher scores indicating worse nightmares

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Disturbing Dreams and Nightmares Severity Index (DDNSI)	5.74 units on a scale Standard Error 0.710	6.44 units on a scale Standard Error 0.718

SECONDARY outcome

Timeframe: 8 weeks of treatment

The Beck Hopelessness Scale is self administered and has 20 'true/false' choices. Some items are reversed scored. The range of scores for the total is 0-20, with higher scores indicating greater hopelessness

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Beck Hopelessness Scale (BHS)	9.40 units on a scale Standard Error 0.58	9.63 units on a scale Standard Error 0.58

SECONDARY outcome

Timeframe: 8 weeks of treatment

This version of the Hamilton Rating Scale for Depression uses 24 items, with a possible total score ranging from 0-74, with higher scores indicating worse depression

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Hamilton Rating Scale for Depression (HAM-D)	14.93 units on a scale Standard Error 0.87	15.89 units on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: 8 weeks of treatment

The Insomnia Severity Index is self rated. It has 7 items, each scored 0-4. Therefore the range of scores is 0-28, with higher scores indicating worse insomnia

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Insomnia Severity Index (ISI)	11.28 units on a scale Standard Error 0.62	13.72 units on a scale Standard Error 0.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks of treatment

This is one of the subscales of the Basis 32. It is self-administered. This subscale has 7 items, each scored 0-4. The totals score is an average of the scores of these 7 items. Higher scores indicate more difficulty with daily living and role functioning.

Outcome measures

Measure	Zolpidem-CR n=51 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale	1.51 units on a scale Standard Error 0.102	1.60 units on a scale Standard Error 0.102

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks of treatment

Population: participants with depression, insomnia, and suicidality

This device measures arm motion over time, reported as "average actigraphic activity Level". The scale is reported as a continuous measure ranging from 0-200, and reported as the average score for each hour for all 24-hours of the day. Higher score represent greater c=activity at that point in time

Outcome measures

Measure	Zolpidem-CR n=37 Participants Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=23 Participants Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Actigraphy	150 units on a scale Standard Error 30	170 units on a scale Standard Error 30

Adverse Events

Zolpidem-CR

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zolpidem-CR n=51 participants at risk Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 participants at risk Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Pregnancy, puerperium and perinatal conditions pregnancy then miscarriage	2.0% 1/51 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care	0.00% 0/52 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care

Other adverse events

Measure	Zolpidem-CR n=51 participants at risk Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks Zolpidem-CR: Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks	Placebo n=52 participants at risk Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks Placebo: Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Respiratory, thoracic and mediastinal disorders cold symptoms and flu	23.5% 12/51 • Number of events 21 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care	17.3% 9/52 • Number of events 9 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care
Nervous system disorders headache	11.8% 6/51 • Number of events 9 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care	11.5% 6/52 • Number of events 11 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care
General disorders Other	7.8% 4/51 • Number of events 14 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care	25.0% 13/52 • Number of events 28 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care
Gastrointestinal disorders nausea and diarrhea	17.6% 9/51 • Number of events 14 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care	17.3% 9/52 • Number of events 14 • 8 weeks randomized care and 2 weeks of follow up after the end of randomized care

Additional Information

William Vaughn McCall

Medical College of Georgia; Augusta University

Phone: 706-721-6719

Email: WMCCALL@augusta.edu

Results disclosure agreements

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