Reducing Suicidal Ideation Through Insomnia Treatment
Condition: Insomnia; Depression; Suicidal Ideation
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Suicidal Ideation
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Zolpidem-CR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Zolpidem 6.25 mg or 12.5 mg 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
Other intervention name(s): Ambien CR
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Depression; Suicidal ideation; Zolpidem CR; Placebo