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Selective Serotonin Reuptake Inhibitor
1 for Insomnia
Phase 4
Waitlist Available
Led By Ian A Cook, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 13
Awards & highlights
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.
Eligible Conditions
- Depression
- Insomnia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cordance value
Secondary outcome measures
Cognitive testing
Depression symptom severity
Serum BDNF
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
Escitalopram and eszopiclone for initial 4 weeks, then switch to escitalopram and placebo for final 4 weeks.
Group II: 1Experimental Treatment1 Intervention
Open label escitalopram plus eszopiclone for 8 weeks
Group III: 3Placebo Group1 Intervention
Escitalopram plus placebo for 8 weeks
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,791 Total Patients Enrolled
6 Trials studying Insomnia
767 Patients Enrolled for Insomnia
Ian A Cook, MDPrincipal InvestigatorSemel Institute for Neuroscience and Human Behavior at UCLA
5 Previous Clinical Trials
220 Total Patients Enrolled
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