CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Eszopiclone +2 moredrug
Likely dose
Eszopiclone 3 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/NCT00247624
NCT00247624Phase 4Completed
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Hypnotics in the Treatment of Psychiatric Disorders

Wake Forest University Health Sciences·interventional·Posted Nov 2, 2005·Updated Aug 28, 2018

In Brief

A Phase 4 clinical trial evaluating Eszopiclone, Fluoxetine, and 1 other intervention for Sleep Initiation and Maintenance Disorders and Depression. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Initiation and Maintenance Disorders, Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Sumitomo Pharma America, Inc., Philips Healthcare

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2005
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.7 years ago

Interventions

Eszopiclonedrug

Eszopiclone 3 mg every night for 8 weeks

Fluoxetinedrug

Fluoxetine 20 mg every morning for 9 weeks

Placebodrug

Placebo every night for 8 weeks