NCT05719909

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
28mo left

Started Feb 2023

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Feb 2023Aug 2028

First Submitted

Initial submission to the registry

January 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 20, 2023

Last Update Submit

January 12, 2026

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Montgomery Asberg Depression Rating Scale

    depression severity; range 0-60; high score=worse outcome

    Trajectories from baseline through 1 month

  • Quick Inventory of Depressive Symptoms

    Self-reported depression (range: 0-27; higher scores = worse outcome)

    Trajectories from baseline through 1 month

Secondary Outcomes (5)

  • Hamilton Depression Rating Scale modified score

    Trajectories from baseline through 1 month

  • Clinical Global Impression Scale--Improvement

    Trajectories from baseline through 1 month

  • Clinical Global Impression Scale--Severity

    Trajectories from baseline through 1 month

  • Frequency of scheduled esketamine visits

    During first month

  • Number of patients terminated from esketamine therapy

    During first 6 months

Other Outcomes (5)

  • Client Satisfaction Questionnaire

    Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)

  • Ease of use

    Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)

  • Helpfulness

    Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)

  • +2 more other outcomes

Study Arms (2)

Cognitive Training

EXPERIMENTAL

8 sessions of web-based cognitive training

Behavioral: Cognitive Training

Sham Training

SHAM COMPARATOR

8 sessions of web-based sham training

Behavioral: Sham Training

Interventions

Cognitive TrainingBEHAVIORAL

8 sessions of web-based cognitive training

Cognitive Training
Sham TrainingBEHAVIORAL

8 sessions of web-based sham training

Sham Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Psychology

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 9, 2023

Study Start

February 14, 2023

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)