Back to resultsTesting the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment
Primary Purpose
Depression
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sham Training
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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: Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment. 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.
Sites / Locations
- Western Psychiatric Institute and Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive Training
Sham Training
Arm Description
8 sessions of web-based cognitive training
8 sessions of web-based sham training
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Secondary Outcome Measures
Hamilton Depression Rating Scale modified score
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Clinical Global Impression Scale--Improvement
range 1-7 (higher score=worse outcome)
Clinical Global Impression Scale--Severity
range 1-7 (higher score=worse outcome)
Frequency of scheduled esketamine visits
The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences
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
Full Information
NCT ID
NCT05719909
First Posted
January 20, 2023
Last Updated
March 2, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05719909
Brief Title
Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment
Official Title
Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
8 sessions of web-based cognitive training
Arm Title
Sham Training
Arm Type
Sham Comparator
Arm Description
8 sessions of web-based sham training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
8 sessions of web-based cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Sham Training
Intervention Description
8 sessions of web-based sham training
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
Trajectories from baseline through 1 month
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
Trajectories from baseline through 1 month
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale modified score
Description
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time Frame
Trajectories from baseline through 1 month
Title
Clinical Global Impression Scale--Improvement
Description
range 1-7 (higher score=worse outcome)
Time Frame
Trajectories from baseline through 1 month
Title
Clinical Global Impression Scale--Severity
Description
range 1-7 (higher score=worse outcome)
Time Frame
Trajectories from baseline through 1 month
Title
Frequency of scheduled esketamine visits
Description
The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences
Time Frame
During first month
Title
Number of patients terminated from esketamine therapy
Description
Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment
Time Frame
During first 6 months
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire
Description
self-reported satisfaction with treatment; range 8-32; higher score=better rating
Time Frame
Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Title
Ease of use
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Title
Helpfulness
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Title
Satisfaction with Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Title
Future likelihood of using Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment.
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.
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment
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