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Brain Mechanisms and Targeting Insomnia in Major Depression

NCT00628914 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-08-20

No results posted yet for this study

Summary

Preliminary studies suggest that the response to antidepressant medication can be accelerated by targeting insomnia with adjunctive use of eszopiclone. It is not yet known what mechanism(s) support this acceleration in response, though preliminary findings support the hypothesis that early restoration of sleep may facilitate BDNF-based effects of antidepressant medications. The optimal duration of co-treatment is also unknown. This study will test specific hypotheses about brain mechanisms and evaluate the effects of continued eszopiclone beyond the time window when response acceleration should be observed.

Conditions

Interventions

DRUG

escitalopram and eszopiclone

escitalopram 10mg tabs QD and eszopiclone 3 mg tabs QD for 8 weeks

DRUG

Escitalopram, eszopiclone, and placebo

Escitalopram 10mg tabs QD for 8 weeks; Eszopiclone 3mg tabs QD for initial 4 weeks then placebo tabs QD for final 4 weeks

DRUG

Escitalopram

Escitalopram 10mg tabs QD and placebo tabs QD for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Ian A Cook, MD · Semel Institute for Neuroscience and Human Behavior at UCLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-11-30
Completion
2010-02-28

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00628914 on ClinicalTrials.gov