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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00247624 |
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.
Condition | Intervention | Phase |
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Sleep Initiation and Maintenance Disorders Depression |
Drug: Eszopiclone Drug: Fluoxetine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Hypnotics in the Treatment of Psychiatric Disorders |
Estimated Enrollment: | 96 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive treatment with eszopiclone and fluoxetine
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Drug: Eszopiclone
Eszopiclone 3 mg every night for 8 weeks
Drug: Fluoxetine
Fluoxetine 20 mg every morning for 9 weeks
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B: Active Comparator
Participants will receive treatment with placebo and fluoxetine
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Drug: Fluoxetine
Fluoxetine 20 mg every morning for 9 weeks
Drug: Placebo
Placebo every night for 8 weeks
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Wake Forest University Health Sciences ( William Vaughn McCall ) |
Study ID Numbers: | R34 MH070821, DSIR 83-ATSO |
Study First Received: | October 31, 2005 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00247624 History of Changes |
Health Authority: | United States: Federal Government |
Depression Hypnotics Sleep |
Quality of Life Insomnia Suicide |
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Depression Psychotropic Drugs Central Nervous System Depressants Suicide Sleep Disorders Dyssomnias Quality of Life Depressive Disorder |
Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Sleep Disorders, Intrinsic Fluoxetine Mental Disorders Hypnotics and Sedatives Mood Disorders Antidepressive Agents, Second-Generation Antidepressive Agents |
Sleep Initiation and Maintenance Disorders Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Sleep Disorders Sleep Disorders, Intrinsic Pathologic Processes Mental Disorders Therapeutic Uses Hypnotics and Sedatives Antidepressive Agents, Second-Generation Antidepressive Agents |
Disease Depression Nervous System Diseases Central Nervous System Depressants Dyssomnias Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Fluoxetine Serotonin Agents Mood Disorders Central Nervous System Agents |