RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Targeted Cognitive Training Intervention for Major Depressive Disorder

The goal of this randomly assigned controlled trial is to measure the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.

Official registry: https://clinicaltrials.gov/study/NCT05877885 · AdventHealth · enrollment listed as 84

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Targeted Cognitive Training Intervention, or General Cognitive Training Intervention. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to measure the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits.

They plan to enroll about 84 people at Orlando. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

Interventions: Targeted Cognitive Training Intervention, General Cognitive Training Intervention

Primary outcome (registry wording): Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks

Who it is for (from inclusion criteria)

Ages 60 Years to any
Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
Montgomery-Åsberg Depression Rating Scale (MADRS) score \> or = 16
Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES \> or = to 37)
Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks
On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks
Capacity to provide written consent for research assessment and treatment
Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff

Who the registry excludes

History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia
Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments
Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy)
Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior
Electroconvulsive therapy within the past 12 months
Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder
Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)

Public study contact (from the registry)

Lauren Oberlin, PhD

(860) 690-8441

lauren.oberlin@adventhealth.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

AdventHealth Neuroscience Institute — Orlando, Florida (recruiting)

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FAQ about this NCT record

Is NCT05877885 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05877885?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05877885?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary