Insomnia | Reducing Suicidal Ideation Through Insomnia Treatment
Insomnia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zolpidem-CRZolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Drug:PlaceboPlacebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Zolpidem-CRZolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
PlaceboPlacebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Start Date: September 2012
Completed Date: January 1, 2018
Phase: Phase 4
Primary Outcome: Suicide Severity Index (SSI)
Secondary Outcome: Dysfunctional Beliefs and Attitudes About Sleep
Study sponsors, principal investigator, and references
Principal Investigator: William V McCall, MD, MS
Lead Sponsor: Augusta University
Collaborator: National Institute of Mental Health (NIMH)