Improving Sleep and Psychological Functioning in People With Depression and Insomnia

NCT00247624 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: R34MH070821DSIR 83-ATSO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Keywords

Depression; Hypnotics; Sleep; Quality of Life; Insomnia; Suicide

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Insomnia Severity Index (ISI)

  9 weeks

Study Arms (2)

A

EXPERIMENTAL

Participants will receive treatment with eszopiclone and fluoxetine

Drug: Eszopiclone; Drug: Fluoxetine

B

ACTIVE COMPARATOR

Participants will receive treatment with placebo and fluoxetine

Drug: Fluoxetine; Drug: Placebo

Interventions

Eszopiclone DRUG

Eszopiclone 3 mg every night for 8 weeks

A

Fluoxetine DRUG

Fluoxetine 20 mg every morning for 9 weeks

A; B

Placebo DRUG

Placebo every night for 8 weeks

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Mental Health (NIMH): collaborator
• Sumitomo Pharma America, Inc.: collaborator
• Philips Healthcare: collaborator

Study Sites (1)

Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (7)

• 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. doi: 10.1046/j.1365-2869.2000.00186.x.

  PMID: 10733688 BACKGROUND

• 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.

  PMID: 10394611 BACKGROUND

• McCall C, McCall WV. Objective vs. subjective measurements of sleep in depressed insomniacs: first night effect or reverse first night effect? J Clin Sleep Med. 2012 Feb 15;8(1):59-65. doi: 10.5664/jcsm.1664.

  PMID: 22334811 DERIVED

• McCall WV, D'Agostino R Jr, Rosenquist PB, Kimball J, Boggs N, Lasater B, Blocker J. Dissection of the factors driving the placebo effect in hypnotic treatment of depressed insomniacs. Sleep Med. 2011 Jun;12(6):557-64. doi: 10.1016/j.sleep.2011.03.008. Epub 2011 May 20.

  PMID: 21601519 DERIVED

• McCall C, McCall WV. Comparison of actigraphy with polysomnography and sleep logs in depressed insomniacs. J Sleep Res. 2012 Feb;21(1):122-7. doi: 10.1111/j.1365-2869.2011.00917.x. Epub 2011 Mar 29.

  PMID: 21447050 DERIVED

• McCall WV, Blocker JN, D'Agostino R Jr, Kimball J, Boggs N, Lasater B, Haskett R, Krystal A, McDonald WM, Rosenquist PB. Treatment of insomnia in depressed insomniacs: effects on health-related quality of life, objective and self-reported sleep, and depression. J Clin Sleep Med. 2010 Aug 15;6(4):322-9.

  PMID: 20726279 DERIVED

• McCall WV, Blocker JN, D'Agostino R Jr, Kimball J, Boggs N, Lasater B, Rosenquist PB. Insomnia severity is an indicator of suicidal ideation during a depression clinical trial. Sleep Med. 2010 Oct;11(9):822-7. doi: 10.1016/j.sleep.2010.04.004. Epub 2010 May 15.

  PMID: 20478741 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Suicide

Interventions

Eszopiclone; Fluoxetine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Vaughn McCall
• Organization: August Health University

wmccall@augusta.edu

706-721-3141

Study Officials

• W. Vaughn McCall, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: October 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 28, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-07

Locations

US (1)