CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Any FDA Approved Antidepressantdrug
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/NCT01916824
NCT01916824Phase 4Completed

Effects of Treatment on Decision-making in Major Depression

Emory University·interventional·Posted Aug 6, 2013·Updated Nov 21, 2017

In Brief

A Phase 4 clinical trial evaluating Any FDA Approved Antidepressant for Major Depressive Disorder and Healthy Controls. Completed, enrolled 53 participants across 1 site.

Detailed Summary

In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 6, 2013
Enrollment StartAug 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.9 years ago

Interventions

Any FDA Approved Antidepressantdrug

Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.