CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Celexa or other antidepressant as clinically indicated +2 moredrug
Likely dose
Celexa or other antidepressant as clinically indicated 20 mgfrom 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/NCT02178696
NCT02178696Phase 4Completed

Predictors of Antidepressant Response

University of Michigan·interventional·Posted Jul 1, 2014·Updated Dec 5, 2017

In Brief

A Phase 4 clinical trial evaluating Placebo, identified as placebo to participants, Celexa or other antidepressant as clinically indicated, and 1 other intervention for Depression. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Major depression is a highly prevalent, frequently debilitating illness that too often fails to respond to currently available treatments such as antidepressant medication. Furthermore, randomized controlled trials of antidepressants consistently demonstrate large placebo effects. The investigators hypothesize that individual differences in the function of key brain circuits underlie the observed variability in clinical responses to both placebo and antidepressant medication. This study will test this hypothesis by recruiting treatment-seeking volunteers with major depression, with or without comorbid nicotine dependence. Volunteers will participate in positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they will receive both placebo and antidepressant medication. A major goal of the study is to improve prediction of individual clinical responses in future treatment trials in which brain imaging may be unavailable, and to study the mechanisms of antidepressant response in Major Depression.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2014
Enrollment StartJan 1, 2011
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.0 years ago

Interventions

Placebo, identified as placebo to participantsother

White tablets

Celexa or other antidepressant as clinically indicateddrug

Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg

Placebo, identifed to participants as "Active medication"other

Blue Capsule