Reducing Suicidal Ideation Through Insomnia Treatment
Condition: Insomnia; Depression; Suicidal Ideation
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Suicidal Ideation
Intervention: Zolpidem-CR; Placebo
Intervention description: 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
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Insomnia; Depression; Suicidal ideation; Zolpidem CR; Placebo

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.
    

Eligibility 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 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