Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2012-12-06
2018-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Sleep-Oriented Intervention for Suicidal Behaviors
NCT01770587
Safety and Efficacy of Chronic Hypnotic Use
NCT01006525
Sleep Treatment for Teens (RCT Phase)
NCT07303959
Sleep Treatment for Teens
NCT05397353
Safety and Efficacy of Chronic Hypnotic Use 2
NCT02456532
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
-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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zolpidem-CR
Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Zolpidem-CR
Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zolpidem-CR
Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Wake Forest University Health Sciences
OTHER
University of Wisconsin, Madison
OTHER
Duke University
OTHER
Augusta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William V McCall, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgia Regents University
Augusta, Georgia, United States
Duke University School of Medicine
Durham, North Carolina, United States
Wake Forest University School of Medicine
Wake Forest, North Carolina, United States
University of Wisconsin- Madison
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
McCall WV, Mercado K, Dzurny TN, McCloud LL, Krystal AD, Benca RM, Rosenquist PB, Looney SW. Insomnia and the effect of zolpidem-extended-release on the sleep items of the Hamilton Rating Scale for Depression in outpatients with depression, insomnia, and suicidal ideation: Relationship to patient age. J Psychopharmacol. 2024 Sep;38(9):827-831. doi: 10.1177/02698811241268900. Epub 2024 Aug 9.
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
McCall WV, Benca RM, Rumble ME, Krystal AD. Blinding and bias in a hypnotic clinical trial. Hum Psychopharmacol. 2021 Jan;36(1):1-5. doi: 10.1002/hup.2757. Epub 2020 Sep 11.
Rumble ME, McCall WV, Dickson DA, Krystal AD, Rosenquist PB, Benca RM. An exploratory analysis of the association of circadian rhythm dysregulation and insomnia with suicidal ideation over the course of treatment in individuals with depression, insomnia, and suicidal ideation. J Clin Sleep Med. 2020 Aug 15;16(8):1311-1319. doi: 10.5664/jcsm.8508.
McCall WV, Benca RM, Rosenquist PB, Youssef NA, McCloud L, Newman JC, Case D, Rumble ME, Szabo ST, Phillips M, Krystal AD. Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial. Am J Psychiatry. 2019 Nov 1;176(11):957-965. doi: 10.1176/appi.ajp.2019.19030267. Epub 2019 Sep 20.
McCall WV, Benca RM, Rumble ME, Case D, Rosenquist PB, Krystal AD. Prevalence of obstructive sleep apnea in suicidal patients with major depressive disorder. J Psychiatr Res. 2019 Sep;116:147-150. doi: 10.1016/j.jpsychires.2019.06.015. Epub 2019 Jun 19.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.