Status:
COMPLETED
Effects of Insomnia Treatment on Metabolism in Patients With Depression
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Insomnia Chronic
Insomnia
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.
Eligibility Criteria
Inclusion
- Insomnia Severity Index \> 14
- Meet diagnostic criteria for Insomnia
- Meet diagnostic criteria for Major Depressive Disorder
- Either currently taking an SSRI/SNRI or no antidepressant
Exclusion
- BMI \> 30
- Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
- Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
- Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
- Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04719143
Start Date
December 20 2018
End Date
December 20 2022
Last Update
January 17 2023
Active Locations (1)
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1
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104