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

Not Applicable

Suspended

• Conditions: Depression
• Interventions: Behavioral: Sham Training; Behavioral: Cognitive Training

• Registration Number: NCT05719909
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-09
• Study Start: 2023-02-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2028-02-28
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Training	Sham Training	8 sessions of web-based sham training
Cognitive Training	Cognitive Training	8 sessions of web-based cognitive training

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptoms	Trajectories from baseline through 1 month	Self-reported depression (range: 0-27; higher scores = worse outcome)
Montgomery Asberg Depression Rating Scale	Trajectories from baseline through 1 month	depression severity; range 0-60; high score=worse outcome

Secondary Outcome Measures

Name	Time	Method
Frequency of scheduled esketamine visits	During first month	The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences
Clinical Global Impression Scale--Severity	Trajectories from baseline through 1 month	range 1-7 (higher score=worse outcome)
Clinical Global Impression Scale--Improvement	Trajectories from baseline through 1 month	range 1-7 (higher score=worse outcome)
Number of patients terminated from esketamine therapy	During first 6 months	Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment
Hamilton Depression Rating Scale modified score	Trajectories from baseline through 1 month	Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States