NCT01689909: REST-IT

Reducing Suicidal Ideation Through Insomnia Treatment

Completed Phase 4 Results posted Last updated 14 February 2022

What this trial tests

Phase 4 trial testing Zolpidem-CR in Insomnia in 103 participants. Completed in 1 January 2018.

Timeline

6 December 2012

Primary endpoint
1 June 2017

1 January 2018

Quick facts

Lead sponsor	Augusta University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	103
Start date	6 December 2012
Primary completion	1 June 2017
Estimated completion	1 January 2018
Sites	4 locations across United States

Drugs / interventions tested

• Zolpidem-CR
• Placebo

Conditions studied

• Insomnia — all drugs for Insomnia →
• Depression — all drugs for Depression →
• Suicidal Ideation — all drugs for Suicidal Ideation →

Sponsor

Augusta University

Who can join

Adults 18 to 65, any sex, with Insomnia or Depression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit.
   Kripke DF. · · 2016 · cited 65× · PMID 27303633 · DOI 10.12688/f1000research.8729.3
2. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder.
   Ballard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, et al · · 2016 · cited 54× · PMID 27337418 · DOI 10.4088/jcp.15m09943
3. An exploratory analysis of the association of circadian rhythm dysregulation and insomnia with suicidal ideation over the course of treatment in individuals with depression, insomnia, and suicidal ideation.
   Rumble ME, McCall WV, Dickson DA, Krystal AD, et al · · 2020 · cited 26× · PMID 32329435 · DOI 10.5664/jcsm.8508
4. A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety.
   McCall WV, Benca RM, Rosenquist PB, Riley MA, et al · · 2015 · cited 18× · PMID 25733676 · DOI 10.1177/1740774515573958
5. Prevalence of obstructive sleep apnea in suicidal patients with major depressive disorder.
   McCall WV, Benca RM, Rumble ME, Case D, et al · · 2019 · cited 16× · PMID 31238203 · DOI 10.1016/j.jpsychires.2019.06.015
6. The effect of zolpidem-CR on the suicide item of the Hamilton Rating Scale for Depression in outpatients with depression, insomnia and suicidal ideation: Lessons learned.
   McCall WV, Mercado K, Dzurny TN, McCloud LL, et al · · 2023 · cited 6× · PMID 37922732 · DOI 10.1016/j.psychres.2023.115576
7. Insomnia and the effect of zolpidem-extended-release on the sleep items of the Hamilton Rating Scale for Depression in outpatients with depression, insomnia, and suicidal ideation: Relationship to patient age.
   McCall WV, Mercado K, Dzurny TN, McCloud LL, et al · · 2024 · cited 4× · PMID 39119911 · DOI 10.1177/02698811241268900