Trial record 19 of 58 for:    insomnia | Open Studies | NIH, U.S. Fed

Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Georgia Regents University
Sponsor:
Collaborators:
Wake Forest School of Medicine
University of Wisconsin, Madison
Duke University
Information provided by (Responsible Party):
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01689909
First received: September 18, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Insomnia
Depression
Suicidal Ideation
Drug: Zolpidem-CR
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Suicidal Ideation Through Insomnia Treatment

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Suicide Severity Index (SSI) [ Time Frame: At the end of 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dysfunctional Beliefs and Attitudes About Sleep [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Disturbing Dreams and Nightmares Severity Index (DDNSI) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Beck Hopelessness Scale (BHS) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Insomnia Severity Index (ISI) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Basis-32 [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
    Health related quality of life (HRQOL)subscales of the Basis-32 (the daily living and role functioning (DLRF) subscale and relationship to self and others subscale (RSO). It will be assessed at each visit.

  • Actigraphy [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
    The participants will wear an actigraph on their non-dominant wrist for the duration of the randomized treatment. Estimates of sleep latency, wake after sleep onset, and total sleep time will be obtained from the medium sensitivity setting at 30-second epochs. We have previously reported that actigraphy tracks polysomnography reasonably-well in depressed insomniacs. Actigraphic data will also be archived for potential future additional data analysis (functional analysis).


Estimated Enrollment: 138
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zolpidem-CR
Zolpidem 6.25 or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Drug: Zolpidem-CR
Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
Other Name: Ambien CR
Placebo Comparator: Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Drug: Placebo
Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
Other Name: Placebo

Detailed Description:

Primary Aim: We will assess the effect of treating insomnia with hypnotic medication on the intensity of suicidal ideation in depressed outpatients with insomnia and suicidal ideation.

-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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 > 40
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689909

Contacts
Contact: William V. McCall, MD, MS 706-721-6719 wmccall@gru.edu
Contact: Mary Anne Riley, MS 706-721-1011 mriley1@gru.edu

Locations
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: McCall    706-721-6719    wmmcall@gru.edu   
Principal Investigator: William V McCall, MD, MS         
Sub-Investigator: Peter Rosenquist, MD         
United States, North Carolina
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Andrew Krystal, MD, MS    919-681-8744    kryst001@mc.duke.edu   
Principal Investigator: Andrew Krystal, MD, MS         
Wake Forest University School of Medicine Not yet recruiting
Wake Forest, North Carolina, United States, 27157
Contact: Doug Case, PhD    336-716-1048    dcase@wakehealth.edu   
Principal Investigator: Doug Case, PhD         
United States, Wisconsin
University of Wisconsin- Madison Recruiting
Madison, Wisconsin, United States, 53719
Contact: Ruth Benca, MD, PhD    608-232-3302    rmbenca@wisc.edu   
Principal Investigator: Ruth Benca, MD, PhD         
Sponsors and Collaborators
Georgia Regents University
Wake Forest School of Medicine
University of Wisconsin, Madison
Duke University
Investigators
Principal Investigator: William V McCall, MD, MS Georgia Regents University
  More Information

Additional Information:
No publications provided

Responsible Party: Georgia Regents University
ClinicalTrials.gov Identifier: NCT01689909     History of Changes
Other Study ID Numbers: 1R01MH095776-01A1, 1R01MH095776
Study First Received: September 18, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Insomnia
Depression
Suicidal ideation
Zolpidem CR
Placebo

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicidal Ideation
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014