NCT04697693

Antidepressant Response in Older Adults With Comorbid PTSD and MDD

Terminated Phase 4 Results posted Last updated 11 May 2022

What this trial tests

Phase 4 trial testing Escitalopram in Post Traumatic Stress Disorder in 1 participant. Terminated before completion.

Timeline

3 March 2021

Primary endpoint
20 May 2021

20 May 2021

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	3 March 2021
Primary completion	20 May 2021
Estimated completion	20 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Escitalopram (escitalopram) — full drug profile →
• Duloxetine (duloxetine) — full drug profile →

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 60 to 105, any sex, with Post Traumatic Stress Disorder or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hamilton Rating Score for Depression (HRSD) From Baseline to Week 8 Primary · Baseline and Week 8

Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 was calculated as Week 8 HRSD - Baseline HRSD.

Group	Value	95% CI
Treatment With Escitalopram or Duloxetine	3	± NA

Sponsor's own description

In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older adults, it has been found that older adults with PTSD frequently meet the criteria for comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and mobility and physical function deficits that are consistent with what the investigator has observed in depressed older adults. Yet, the investigator has found that very few older adults with combined PTSD/MDD have received appropriate antidepressant treatment for their condition. These findings give rise to the questions of (1) how effective is antidepressant treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and physical function deficits in PTSD/MDD patients reversible with effective antidepressant treatment?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.