Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment

Depression Clinical Trial

Official title:

Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05719909
• Other study ID #: STUDY22090145
• Status: Suspended
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a sample of patients already receiving esketamine treatment as part of their clinical care, this project seeks to test whether we can improve depression by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Any patient aged 18-80 in the esketamine clinic in the Center for Interventional Psychiatry. The clinic's extensive screening and eligibility criteria for esketamine treatment will not be altered in any way, other than imposing the study-specific age range and the two exclusion criteria below.

Exclusion Criteria:

1. Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment.

2. Patients who, in the judgment of the esketamine clinical medical director, show signs of intellectual disability, developmental disability, and/or cognitive impairment (including age-related cognitive decline) of a sufficient degree to interfere with engagement in any study procedure.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Cognitive Training
8 sessions of web-based cognitive training
• Sham Training
8 sessions of web-based sham training

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire	self-reported satisfaction with treatment; range 8-32; higher score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Other	Ease of use	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Other	Helpfulness	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Other	Satisfaction with Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Other	Future likelihood of using Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	Trajectories from baseline through 1 month
Primary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	Trajectories from baseline through 1 month
Secondary	Hamilton Depression Rating Scale modified score	Clinician-rated depression (range: 0-52; higher scores = worse outcome)	Trajectories from baseline through 1 month
Secondary	Clinical Global Impression Scale--Improvement	range 1-7 (higher score=worse outcome)	Trajectories from baseline through 1 month
Secondary	Clinical Global Impression Scale--Severity	range 1-7 (higher score=worse outcome)	Trajectories from baseline through 1 month
Secondary	Frequency of scheduled esketamine visits	The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences	During first month
Secondary	Number of patients terminated from esketamine therapy	Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment	During first 6 months