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 : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Depression Suicidal Ideation||Drug: Zolpidem-CR Drug: Placebo||Phase 4|
Primary Aim: We will assess the effect of treating insomnia with hypnotic medication on the intensity of suicidal ideation in depressed outpatients with insomnia and suicidal ideation.
-Hypothesis 1. Treatment of depressed, insomniac and suicidal outpatients with open-label fluoxetine (FLX) and blinded zolpidem controlled release (ZOL) will reduce suicidal ideation more than treatment with FLX and blinded placebo.
Secondary Aim: We will examine whether reduced suicidal ideation in depressed insomniacs is mediated through reduced dysfunctional beliefs about sleep, reduced hopelessness, or fewer nightmares.
- Hypothesis 2a. Reduction in suicidal ideation will be mediated through reductions in dysfunctional beliefs about sleep.
- Hypothesis 2b. Reduction in suicidal ideation will be mediated through reductions in hopelessness.
- Hypothesis 2c. Reduction in suicidal ideation is mediated through fewer nightmares.
Tertiary Aim: We will confirm findings from our prior pilot studies that treatment of insomnia in depressed insomniacs leads to improvements in health-related quality of life, especially in women.
Exploratory Aim: We will archive actigraphy data to permit future examination to confirm our preliminary data that actigraphic activity decreases as suicidal ideation resolves.
Overview of the Need for and Management of a Collaborative Application: The sample sizes required to satisfy the Aims are relatively large, necessitating the pooled recruiting resources of 3 sites. Georgia Regents University (GRU) will serve both as the coordinating/data management site, as well as a recruiting site, with Duke and Wisconsin as recruiting sites. Project management will be coordinated through an Executive Committee of site principal investigators, under the supervision of a Data and Safety Monitoring Board.
Impact on the Field: This application has the potential to change providers' practice in the approach to treating insomnia in depressed patients with mild-moderate suicidal ideation. It may also reveal the mechanisms whereby insomnia increases the risk for suicidal ideation and behavior, and begin to examine whether there is an actigraphic "signature" for reductions in suicidal ideation. When these lessons are applied to the clinical world, they can be applied with low cost.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reducing Suicidal Ideation Through Insomnia Treatment|
|Actual Study Start Date :||December 6, 2012|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||January 1, 2018|
Active Comparator: Zolpidem-CR
Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Other Name: Ambien CR
Placebo Comparator: Placebo
Placebo 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
- Scale for Suicide Ideation Index (SSI) [ Time Frame: 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
- Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale [ Time Frame: 8 weeks of treatment ]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
- Dysfunctional Beliefs and Attitudes About Sleep [ Time Frame: 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
- Disturbing Dreams and Nightmares Severity Index (DDNSI) [ Time Frame: 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
- Beck Hopelessness Scale (BHS) [ Time Frame: 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
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 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
- Insomnia Severity Index (ISI) [ Time Frame: 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
- Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale [ Time Frame: 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.
- Actigraphy [ Time Frame: 8 weeks of treatment ]This device measures arm motion over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689909
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|United States, North Carolina|
|Duke University School of Medicine|
|Durham, North Carolina, United States, 27710|
|Wake Forest University School of Medicine|
|Wake Forest, North Carolina, United States, 27157|
|United States, Wisconsin|
|University of Wisconsin- Madison|
|Madison, Wisconsin, United States, 53719|
|Principal Investigator:||William V McCall, MD, MS||Augusta University|