Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Depression Clinical Trial

Official title:

Hypnotics in the Treatment of Psychiatric Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247624
• Other study ID #: R34MH070821
• Secondary ID: DSIR 83-ATSOR34M
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Score of greater than 10 on the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eszopiclone
Eszopiclone 3 mg every night for 8 weeks
• Fluoxetine
Fluoxetine 20 mg every morning for 9 weeks
• Placebo
Placebo every night for 8 weeks

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute of Mental Health (NIMH), Philips Healthcare, Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings	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.	9 weeks
Primary	Relation to Self/Others (RSO) Basis-32 Subscale Ratings	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.	9 weeks
Primary	Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	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.	9 weeks
Secondary	Insomnia Severity Index (ISI)	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).	9 weeks