Reducing Suicidal Ideation Through Insomnia Treatment

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Collaborators: Duke University; National Institute of Mental Health (NIMH); University of Wisconsin, Madison; Wake Forest University Health Sciences
• Treatments: Zolpidem

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