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Improving Sleep and Psychological Functioning in People With Depression and Insomnia

NCT00247624 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-28

Study results available
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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

Interventions

DRUG

Eszopiclone

Eszopiclone 3 mg every night for 8 weeks

DRUG

Fluoxetine

Fluoxetine 20 mg every morning for 9 weeks

DRUG

Placebo

Placebo every night for 8 weeks

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Philips Healthcare

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • W. Vaughn McCall, MD, MS · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-10-31
Completion
2008-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00247624 on ClinicalTrials.gov