Completed

Effects of Insomnia Treatment on Metabolism in Patients With Depression

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What is being tested

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral
Who is being recruted

Behavior+6

+ Mental Disorders

+ Behavioral Symptoms

From 21 to 60 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: December 2018
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 20, 2018

Actual date on which the first participant was enrolled.

This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.

Official TitleEffects of Insomnia Treatment on Metabolism in Patients With Depression
NCT04719143
Principal SponsorUniversity of Pennsylvania
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressionSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

4 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The University of Pennsylvania

Philadelphia, United StatesOpen The University of Pennsylvania in Google Maps
CompletedOne Study Center