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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Depression Suicidal Ideation Drug: Zolpidem-CR Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Suicidal Ideation Through Insomnia Treatment
Actual Study Start Date : September 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 Name: 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




Primary Outcome Measures :
  1. Suicide Severity Index (SSI) [ Time Frame: At the end of 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. 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.

  2. Actigraphy [ Time Frame: 8 weeks of treatment ]
    This device measures arm motion over time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Suicidal Ideation (SSI) scores >3 but <15 OR SSI >15 and C-SSRS Suicidal Ideation Score <3
  • 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 Severe suicidal ideation (SSI > 15 AND C-SSRS Suicidal Ideation Score >4)
  • 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 excessive daytime sleepiness, defined as an Epworth Sleepiness Scale Score >10
  • 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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Augusta University
National Institute of Mental Health (NIMH)
Wake Forest University Health Sciences
University of Wisconsin, Madison
Duke University
Investigators
Principal Investigator: William V McCall, MD, MS Augusta University
  Study Documents (Full-Text)

Documents provided by Augusta University:

Additional Information:
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 Posted: September 21, 2012    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: June 2018

Keywords provided by Augusta University:
Insomnia
Depression
Suicidal ideation
Zolpidem CR
Placebo

Additional relevant MeSH terms:
Depression
Sleep Initiation and Maintenance Disorders
Suicidal Ideation
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Suicide
Self-Injurious Behavior
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action