CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
Zolpidem-CR +1 moredrug
Likely dose
Zolpidem-CR 6.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01689909
NCT01689909Phase 4Completed

Reducing Suicidal Ideation Through Insomnia Treatment

Augusta University·interventional·Posted Sep 21, 2012·Updated Feb 16, 2022

In Brief

A Phase 4 clinical trial evaluating Zolpidem-CR and Placebo for Insomnia and 2 related conditions. Completed, enrolled 103 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartDec 6, 2012
Primary CompletionJun 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.8 years ago

Interventions

Zolpidem-CRdrug

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

Placebodrug

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