Improving Sleep and Psychological Functioning in People With Depression and Insomnia

July 30, 2018 updated by: Wake Forest University Health Sciences

Hypnotics in the Treatment of Psychiatric Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Active Comparator: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute of Mental Health (NIMH)
Philips Healthcare
Sunovion

Investigators

  • Principal Investigator: W. Vaughn McCall, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH070821 (U.S. NIH Grant/Contract)
  • DSIR 83-ATSO (National Institute of Mental Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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