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Reducing Suicidal Ideation Through Insomnia Treatment

NCT01689909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-02-16

Study results available
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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.

Conditions

Interventions

DRUG

Zolpidem-CR

Zolpidem 6.25 mg or 12.5 mg 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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Wake Forest University Health Sciences

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Augusta University

    lead OTHER

Principal Investigators

  • William V McCall, MD, MS · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-06
Primary Completion
2017-06-30
Completion
2018-01-01

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689909 on ClinicalTrials.gov