Effects of Insomnia Treatment on Metabolism in Patients With Depression

Depression Clinical Trial

Official title:

Effects of Insomnia Treatment on Metabolism in Patients With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719143
• Other study ID #: 831841
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 20, 2022

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms
• Insomnia
• Insomnia Chronic
• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBT-I)
Subjects receive 6-8 CBT-I sessions in an individual format.

Locations

Country	Name	City	State
United States	The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic Assays	Blood samples will be collected at enrollment . We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.	Baseline (week 0)
Primary	Metabolomic Assays	Blood samples will be collected 2 weeks following the completion of CBT-I to examine metabolic markers of response to CBT-I. We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.	2 weeks post-treatment (week 10 on average)
Primary	Insomnia Severity Index	A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.	Baseline (week 0)
Primary	Insomnia Severity Index	A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.	2 weeks post-treatment (week 10 on average)
Primary	Insomnia Severity Index	A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.	3 months post-treatment (week 20 on average)