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NCT01931202 · ClinicalTrials.gov registry record · NA

Mechanisms of Antidepressant Non-Response in Late-Life Depression

A NA study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
NA
Development phase
138
Enrollment target

NCT01931202 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 138 participants.

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The verdict

NCT01931202, a NA study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
NA
Development phase
138 participants
Enrollment target

Study Summary

This project seeks to elucidate the mechanisms by which antidepressant medications have limited efficacy in Late Life Depression (LLD) in order to develop new treatment interventions for this prevalent and disabling illness. Investigators hypothesize that the presence of executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability to form appropriate expectancies of improvement with antidepressant treatment. Greater expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and decrease the efficacy of antidepressant medications by disrupting connections between prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter tracts may also compromise the pathway by which expectancy-based placebo effects influence depressive symptoms. Expectancies reflect activation in PFC areas that may improve depressive symptoms by modulating the activity of subcortical regions subserving negative affective systems (i.e., amygdala) as well as those important in reward and hedonic capacity (nucleus accumbens and ventral striatum). Thus, LLD patients with ED and WMH may sustain a "double-hit" to their ability to experience placebo effects in antidepressant treatments: ED diminishes the ability to generate appropriate treatment expectancies, while WMH disrupt the physiologic pathways by which expectancies lead to improvement in depressive symptoms.

Interventions

  • DRUG Escitalopram
  • DRUG Placebo oral tablet

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2014-02-19
Est. Completion 2020-01-17
Phase NA

What the Registry Record Tells You About NCT01931202

The ClinicalTrials.gov registry entry for NCT01931202 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Escitalopram is the first listed.

NCT01931202 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01931202 about?

NCT01931202 is a clinical study titled "Mechanisms of Antidepressant Non-Response in Late-Life Depression". This project seeks to elucidate the mechanisms by which antidepressant medications have limited efficacy in Late Life Depression (LLD) in order to develop new treatment interventions for this prevalent and disabling illness. Investigators hypothesize that the presence of executive dysfunction (ED),w...

What is the current status of trial NCT01931202?

This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2014-02-19. Estimated completion is 2020-01-17.

What interventions are being tested in trial NCT01931202?

The interventions under investigation include: Escitalopram (DRUG), Placebo oral tablet (DRUG).

Who is sponsoring clinical trial NCT01931202?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.