Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)

February 14, 2022 updated by: Augusta University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University School of Medicine
      • Wake Forest, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • University of Wisconsin- Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons 18-65 years of age
  • Persons with confirmed DSM-IV diagnosis of MDE by SCID
  • Persons with Research Diagnostic Criteria diagnosis of insomnia
  • Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence.
  • Persons with Scale for Suicide Ideation (SSI) scores >2
  • Persons with Hamilton Rating Scale for Depression (HRSD24) score >20
  • Persons with Mini Mental State Exam (MMSE) score >24
  • Persons with Insomnia Severity Index (ISI) score > 7
  • Persons with habitual sleep latency > or = 30 minutes or wake time in the middle of the night of > or = 30 minutes, and sleep efficiency < 85%

Exclusion Criteria:

  • Non-English speaking, reading, writing persons
  • Persons who pose imminent danger to self or others
  • Persons with severe suicidal ideation (C-SSRS Suicidal Ideation Score >3)
  • Persons with clinical diagnosis of dementia
  • Persons with active or past diagnosis of alcohol or substance abuse, bipolar disorder, schizophrenia per the SCID
  • Persons who screen positive for moderate-severe sleep apnea (AHI >10) or a prior sleep laboratory-confirmed diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder.
  • Persons with BMI > 50
  • Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs)
  • Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zolpidem-CR
Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Drug: Zolpidem-CR
Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Other Names:
  • Ambien CR
Placebo Comparator: Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Drug: Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Over 8 weeks of treatment
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
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks of treatment
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
8 weeks of treatment
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
8 weeks of treatment
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
8 weeks of treatment
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
8 weeks of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks of treatment
Actigraphy
Time Frame: 8 weeks of treatment
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
8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

National Institute of Mental Health (NIMH)
University of Wisconsin, Madison
Duke University
Wake Forest University Health Sciences

Investigators

  • Principal Investigator: William V McCall, MD, MS, Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH095776-01A1 (U.S. NIH Grant/Contract)
  • 1R01MH095776 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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