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Trial record 13 of 119 for:    zolpidem AND Hypnotics

Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)

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ClinicalTrials.gov Identifier: NCT01689909
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Wake Forest University Health Sciences
University of Wisconsin, Madison
Duke University
Information provided by (Responsible Party):
Augusta University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Insomnia
Depression
Suicidal Ideation
Interventions Drug: Zolpidem-CR
Drug: Placebo
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 51 52
Completed 51 52
Not Completed 0 0
Arm/Group Title Zolpidem-CR Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 51 52 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
52
 100.0%
103
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 103 participants
39.7  (14.5) 41.2  (12.0) 40.5  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Female
32
  62.7%
32
  61.5%
64
  62.1%
Male
19
  37.3%
20
  38.5%
39
  37.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Hispanic or Latino
4
   7.8%
1
   1.9%
5
   4.9%
Not Hispanic or Latino
47
  92.2%
51
  98.1%
98
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   9.8%
2
   3.8%
7
   6.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  23.5%
16
  30.8%
28
  27.2%
White
34
  66.7%
34
  65.4%
68
  66.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 52 participants 103 participants
51 52 103
Scale for Suicide Ideation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 52 participants 103 participants
12.2  (5.3) 11.8  (5.3) 12.0  (5.3)
[1]
Measure Description: 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
Hamilton Rating Scale for Depression -24   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 52 participants 103 participants
28.7  (4.7) 29.6  (7.0) 29.1  (5.9)
[1]
Measure Description: 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
Disturbing Dreams Nightmare Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 52 participants 103 participants
10.5  (8.8) 10.2  (7.7) 10.3  (8.2)
[1]
Measure Description: 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
Insomnia Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 52 participants 103 participants
20.6  (3.9) 21.1  (4.3) 20.8  (4.1)
[1]
Measure Description: 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
1.Primary Outcome
Title Suicide Severity Index (SSI)
Hide Description 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
Time Frame At the end of 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.66  (0.58) 5.25  (0.59)
2.Secondary Outcome
Title Dysfunctional Beliefs and Attitudes About Sleep
Hide Description 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
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.03  (0.171) 6.07  (0.171)
3.Secondary Outcome
Title Disturbing Dreams and Nightmares Severity Index (DDNSI)
Hide Description 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
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.74  (0.710) 6.44  (0.718)
4.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description 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
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.40  (0.58) 9.63  (0.58)
5.Secondary Outcome
Title Hamilton Rating Scale for Depression (HAM-D)
Hide Description 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
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
14.93  (0.87) 15.89  (0.88)
6.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description 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
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.28  (0.62) 13.72  (0.63)
7.Other Pre-specified Outcome
Title Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale
Hide Description 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.
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 51 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.51  (0.102) 1.60  (0.102)
8.Other Pre-specified Outcome
Title Actigraphy
Hide Description This device measures arm motion over time.
Time Frame 8 weeks of treatment
Outcome Measure Data Not Reported
Time Frame 8 weeks randomized care and 2 weeks of follow up after the end of randomized care
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem-CR Placebo
Hide Arm/Group Description

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 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

All-Cause Mortality
Zolpidem-CR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/52 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem-CR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      0/52 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
pregnancy then miscarriage * [1]  1/51 (1.96%)  0/52 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Despite being cautioned about the need for birth-control, a female participant nevertheless became pregnant (by her report), and shortly thereafter miscarried (by her report). She had a history of multiple prior miscarriages.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem-CR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/51 (60.78%)      37/52 (71.15%)    
Gastrointestinal disorders     
nausea and diarrhea *  9/51 (17.65%)  14 9/52 (17.31%)  14
General disorders     
Other *  4/51 (7.84%)  14 13/52 (25.00%)  28
Nervous system disorders     
headache *  6/51 (11.76%)  9 6/52 (11.54%)  11
Respiratory, thoracic and mediastinal disorders     
cold symptoms and flu *  12/51 (23.53%)  21 9/52 (17.31%)  9
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: William Vaughn McCall
Organization: Medical College of Georgia; Augusta University
Phone: 706-721-6719
Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT01689909     History of Changes
Other Study ID Numbers: 1R01MH095776-01A1 ( U.S. NIH Grant/Contract )
1R01MH095776 ( U.S. NIH Grant/Contract )
First Submitted: September 18, 2012
First Posted: September 21, 2012
Results First Submitted: April 13, 2018
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018