DepressionNCT05719909
Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment
A study testing Cognitive Training in people with Depression, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment
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.
- Conditions
- Depression
- Being tested
- Cognitive Training, Sham Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
8 sessions of web-based cognitive training
Sham TrainingBehavioural
8 sessions of web-based sham training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | 8 sessions of web-based cognitive training Receives: Behavioral: Cognitive Training |
| Sham Training | Sham comparator | 8 sessions of web-based sham training Receives: Behavioral: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from baseline through 1 month
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from baseline through 1 month
Secondary outcomes (5)
Hamilton Depression Rating Scale modified score
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Measured: Trajectories from baseline through 1 month
Clinical Global Impression Scale--Improvement
range 1-7 (higher score=worse outcome)
Measured: Trajectories from baseline through 1 month
Clinical Global Impression Scale--Severity
range 1-7 (higher score=worse outcome)
Measured: Trajectories from baseline through 1 month
Frequency of scheduled esketamine visits
The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences
Measured: During first month
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
Measured: During first 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start14 Feb 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: Current unavailability of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Price, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719909
- Sponsor's protocol ID
- STUDY22090145
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment
- ClinicalTrials.gov ID
- NCT05719909
- Acronym / sponsor ID
- STUDY22090145
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Current unavailability of resources
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive Training8 sessions of web-based cognitive training |
| Sham Training | Sham comparator | Behavioral: Sham Training8 sessions of web-based sham training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Training8 sessions of web-based cognitive training | Behavioural | Cognitive Training |
| Sham Training8 sessions of web-based sham training | Behavioural | Sham Training |
Primary outcome
Montgomery Asberg Depression Rating Scale
Time frame: Trajectories from baseline through 1 month
depression severity; range 0-60; high score=worse outcome
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from baseline through 1 month
Self-reported depression (range: 0-27; higher scores = worse outcome)
5 secondary outcomes
Hamilton Depression Rating Scale modified score
Time frame: Trajectories from baseline through 1 month
Clinical Global Impression Scale--Improvement
Time frame: Trajectories from baseline through 1 month
Clinical Global Impression Scale--Severity
Time frame: Trajectories from baseline through 1 month
Frequency of scheduled esketamine visits
Time frame: During first month
Number of patients terminated from esketamine therapy
Time frame: During first 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (time frame: Trajectories from baseline through 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.