Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)

A

Augusta University

Status and phase

Completed
Phase 4

Conditions

Suicidal Ideation
Insomnia
Depression

Treatments

Drug: Zolpidem-CR
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01689909
1R01MH095776 (U.S. NIH Grant/Contract)
1R01MH095776-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

103 participants in 2 patient groups, including a placebo group

Zolpidem-CR
Active Comparator group
Description:
Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Treatment:
Drug: Zolpidem-CR
Placebo
Placebo Comparator group
Description:
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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