CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
clinical assessmentsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04189939
NCT04189939N/ACompleted

Computational Psychiatric Approach for Prognosis of Medication-Resistant Depression

Wake Forest University Health Sciences·observational·Posted Dec 6, 2019·Updated Aug 6, 2024

In Brief

An observational study evaluating clinical assessments for Depression and Treatment Resistant Depression. Completed, enrolled 128 participants across 1 site.

Detailed Summary

The purpose of this research is to investigate how the brain changes in patients undergoing electroconvulsive (ECT) treatment for depression. Subjects will be invited to be in this study because (1) they are a patient about to receive ECT treatment for depression, or (2) they are a patient diagnosed with depression and do not qualify for ECT treatment, or (3) they are a healthy adult volunteer with no history of depression. All volunteers must be between the ages of 18-85. Participation in this research will involve three visits. Each visit will last about 3-4 hours. If the subject is a patient receiving ECT for depression the study team will schedule study visits to go along with patient treatment visits. If the subject is diagnosed with depression (not treatment-resistant depression) or are a healthy volunteer, their first visit will be scheduled at their convenience, followed by a second visit 1-3 months post visit one and a third visit 1-2 months post visit two, for a total of three research visits. Participation in this research will involve playing simple computer games while the subject's brain is scanned with magnetic resonance imaging (MRI). Additionally, the study team will assess symptoms of depression using questionnaires. Patients receiving ECT will not experience any changes to their standard of care ECT treatment plan. Healthy and non-treatment resistant depressed volunteers will not undergo ECT treatment.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 6, 2019
Enrollment StartMar 9, 2020
Primary CompletionMay 22, 2023
Study CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.6 years ago

Interventions

clinical assessmentsother

Behavioral tasks will be executed via a computer interface. Below, we provide an estimated timeline for each visit and subsequently provide detail for the relevant stages. Each participant's visit will last approximately 4-5 hours. Each visit will consist of the following tasks (in this order):