Improving Sleep and Psychological Functioning in People With Depression and Insomnia
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|ClinicalTrials.gov Identifier: NCT00247624|
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : December 13, 2017
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders Depression||Drug: Eszopiclone Drug: Fluoxetine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Hypnotics in the Treatment of Psychiatric Disorders|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2008|
Participants will receive treatment with eszopiclone and fluoxetine
Eszopiclone 3 mg every night for 8 weeks
Fluoxetine 20 mg every morning for 9 weeks
Active Comparator: B
Participants will receive treatment with placebo and fluoxetine
Fluoxetine 20 mg every morning for 9 weeks
Placebo every night for 8 weeks
- Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings [ Time Frame: 9 weeks ]The BASIS 32 psychometric includes several subscales, including "daily living and role functioning" (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks.
- Relation to Self/Others (RSO) Basis-32 Subscale Ratings [ Time Frame: 9 weeks ]The BASIS 32 psychometric includes several subscales, including "relation to self and others" (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks.
- Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 9 weeks ]The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks.
- Insomnia Severity Index (ISI) [ Time Frame: 9 weeks ]The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247624
|United States, North Carolina|
|Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||W. Vaughn McCall, MD, MS||Wake Forest University Health Sciences|