NCT00247624

Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Hypnotics in the Treatment of Psychiatric Disorders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as poor quality of life and increased risk of suicide. Studies have shown that treating insomnia during a major depressive episode may not only help reduce symptoms of major depression during the day, but also improve an individual's general quality of life. Thus, sleeping pills, also known as hypnotics, are commonly prescribed for people with psychiatric disorders. However, little is known about the safety and efficacy of combining sleeping pills with antidepressant medications. 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. Participants in this double-blind study will first receive fluoxetine, an antidepressant medication, for 1 week. Participants whose symptoms of insomnia subside after this initial week will continue on fluoxetine for the duration of the study and will not receive sleeping pills. Those who do not experience an improvement in their symptoms of insomnia after 1 week will be randomly assigned to receive either placebo or eszopiclone, which is a sleeping pill, in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend study visits at various points throughout the treatment phase. Follow up visits will occur periodically over the next 4 months. Assessments will include physiological measures during sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of movement during sleep.

Conditions

• Sleep Initiation and Maintenance Disorders
• Depression

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg every night for 8 weeks
DRUG	Fluoxetine	Fluoxetine 20 mg every morning for 9 weeks
DRUG	Placebo	Placebo every night for 8 weeks

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2005-11-02
• Last updated: 2018-08-28
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study