Improving Sleep and Psychological Functioning in People With Depression and Insomnia - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00247624

Purpose

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
Sleep Initiation and Maintenance Disorders Depression	Drug: Eszopiclone Drug: Fluoxetine Drug: Placebo	Phase IV

MedlinePlus related topics: Depression Mental Health

Drug Information available for: Fluoxetine Fluoxetine hydrochloride Eszopiclone

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

"Role Functioning" and "Relation to Self/Others" Basis-32 subscale ratings [ Time Frame: Measured weekly for 9 weeks ] [ Designated as safety issue: No ]
Quality of life ratings, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Measured weekly for 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective sleep symptoms (perceived sleep onset latency, perceived total sleep time, number of awakenings, final rising time, and the presence and duration of any naps the prior day) [ Time Frame: Measured weekly for 10 weeks ] [ Designated as safety issue: No ]
Insomnia symptoms, as measured by the Insomnia Severity Index (ISI) [ Time Frame: Measured weekly for 10 weeks ] [ Designated as safety issue: No ]

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
A: Experimental Participants will receive treatment with eszopiclone and fluoxetine	Drug: Eszopiclone Eszopiclone 3 mg every night for 8 weeks Drug: Fluoxetine Fluoxetine 20 mg every morning for 9 weeks
B: Active Comparator Participants will receive treatment with placebo and fluoxetine	Drug: Fluoxetine Fluoxetine 20 mg every morning for 9 weeks Drug: Placebo Placebo every night for 8 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Score of greater than 10 on the PRIME-MD-PHQ telephone screen
Diagnosis of major depressive episode based on the Structured Clinical Interview for DSM-IV (SCID)
Score of greater than 20 on the Hamilton Rating Scale for Depression
Meets research diagnostic criteria for insomnia disorder at least 4 nights per week
Reported mean sleep latency greater than 30 minutes and mean sleep efficiency less than 85%
Suitable for outpatient treatment

Exclusion Criteria:

Use of any psychotropic medications within 2 weeks of initial screening
Bipolar disorder, schizophrenia, psychotic depression, or any other psychotic disorder
Uncontrolled asthma or chronic obstructive pulmonary disease
Chronic pain that may be a significant sleep-disturbing factor
Uncontrolled thyroid disease
Poorly controlled diabetes mellitus
Poorly compensated congestive heart failure
Currently taking lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep
History of intolerance or treatment resistance to either fluoxetine or eszopiclone
Inability to abstain from taking any psychotropics other than the study medications during the course of the protocol, including sedating antihistamines
Use of any herbal or naturopathic treatments for sleep or mood (i.e., St. John's wort, melatonin, kava kava, valerian root, etc.)
Currently undergoing behavioral, cognitive-behavioral, or interpersonal therapy
Pregnant or breastfeeding
Agrees to use an effective form of contraception for the duration of the study
Uncontrolled symptoms of menopause, including hot flashes
Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mm Hg, diastolic blood pressure consistently greater than 90 mm Hg)
Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome
Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times per week
Reports habitual rising time later than 9 AM more than 2 times per week
Body mass index greater than 30
Consumes more than 3 alcoholic beverages per day
Consumes more than 4 caffeinated beverages per day
Habitual smoking between 11 PM and 7 AM
Use of illicit drugs
Score greater than 24 on the Mini Mental State Examination
Determined to be incompetent
Determined to be at imminent risk for suicide
More than 5 lifetime SCID diagnoses of major depressive episodes
More than 3 failed antidepressant trials during the current episode of depression, as determined by the Antidepressant Treatment History Form
A course of electroconvulsive therapy during the present depressive episode

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247624

Contacts

Contact: Niki G. Boggs	336-716-5113	nboggs@wfubmc.edu
Contact: W. Vaughn McCall, MD, MS	336-716-2911	vmccall@wfubmc.edu

Locations

United States, North Carolina
Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Niki G. Boggs 336-716-5113 nboggs@wfubmc.edu
Principal Investigator: W. Vaughn McCall, MD, MS

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

W. Vaughn McCall, MD, MS

Wake Forest University

More Information

Click Here for More Information on This Study at The American Insomnia Association [AIA] Home Page This link exits the ClinicalTrials.gov site

Publications:

McCall WV, Reboussin BA, Cohen W. Subjective measurement of insomnia and quality of life in depressed inpatients. J Sleep Res. 2000 Mar;9(1):43-8.

Zammit GK, Weiner J, Damato N, Sillup GP, McMillan CA. Quality of life in people with insomnia. Sleep. 1999 May 1;22 Suppl 2:S379-85.

Responsible Party:	Wake Forest University Health Sciences ( William Vaughn McCall )
Study ID Numbers:	R34 MH70821, DSIR 83-ATSO
Study First Received:	October 31, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00247624
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Depression
Hypnotics
Sleep

Quality of Life
Insomnia
Suicide

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Depression
Suicide
Sleep Disorders
Dyssomnias
Quality of Life
Depressive Disorder

Serotonin
Behavioral Symptoms
Sleep Disorders, Intrinsic
Fluoxetine
Mental Disorders
Mood Disorders

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009