NCT01689909

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 20, 2018

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

4.5 years

First QC Date

September 18, 2012

Results QC Date

April 13, 2018

Last Update Submit

February 14, 2022

Conditions

InsomniaDepressionSuicidal Ideation

Keywords

InsomniaDepressionSuicidal ideationZolpidem CRPlacebo

Outcome Measures

Primary Outcomes (2)

  • Scale for Suicide Ideation Index (SSI)

    This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation

    Over 8 weeks of treatment

  • Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale

    The suicide ideation scale of the C-SSRS is rated 0-5, with "0" meaning no suicidal ideation, "1" meaning a wish t be dead, "2" meaning non-specific active suicidal thoughts, "3" meaning active suicidal ideation with any methods but no plan or intent, "4" meaning active suicidal ideation with some intent but no specific plan, and "5" meaning active suicidal ideation with intent and a specific plan

    8 weeks of treatment

Secondary Outcomes (5)

  • Dysfunctional Beliefs and Attitudes About Sleep

    8 weeks of treatment

  • Disturbing Dreams and Nightmares Severity Index (DDNSI)

    8 weeks of treatment

  • Beck Hopelessness Scale (BHS)

    8 weeks of treatment

  • Hamilton Rating Scale for Depression (HAM-D)

    8 weeks of treatment

  • Insomnia Severity Index (ISI)

    8 weeks of treatment

Other Outcomes (2)

  • Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale

    8 weeks of treatment

  • Actigraphy

    8 weeks of treatment

Study Arms (2)

Zolpidem-CR

ACTIVE COMPARATOR

Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks

Drug: Zolpidem-CR

Placebo

PLACEBO COMPARATOR

Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks

Drug: Placebo

Interventions

Zolpidem-CRDRUG

Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks

Also known as: Ambien CR
Zolpidem-CR
PlaceboDRUG

Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Wake Forest University School of Medicine

Wake Forest, North Carolina, 27157, United States

Location

University of Wisconsin- Madison

Madison, Wisconsin, 53719, United States

Location

Related Publications (6)

  • 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.

    PMID: 39119911DERIVED

  • 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.

    PMID: 33884617DERIVED

  • 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.

    PMID: 32918323DERIVED

  • 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.

    PMID: 32329435DERIVED

  • 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.

    PMID: 31537089DERIVED

  • 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.

    PMID: 31238203DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionSuicidal Ideation

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
William Vaughn McCall
Organization
Medical College of Georgia; Augusta University
WMCCALL@augusta.edu
706-721-6719

Study Officials

  • William V McCall, MD, MS

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 21, 2012

Study Start

December 6, 2012

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

February 16, 2022

Results First Posted

June 20, 2018

Record last verified: 2022-02

Locations

US(4)