Antidepressant Response in Older Adults With Comorbid PTSD and MDD

NCT04697693 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 8111
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Post Traumatic Stress Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Rating Score for Depression (HRSD) From Baseline to 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.

  Baseline and Week 8

Study Arms (1)

Treatment with escitalopram or duloxetine

EXPERIMENTAL

Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study

Drug: Escitalopram; Drug: Duloxetine

Interventions

Escitalopram DRUG

The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.

Also known as: lexapro

Treatment with escitalopram or duloxetine

Duloxetine DRUG

Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.

Also known as: cymbalta

Treatment with escitalopram or duloxetine

Eligibility Criteria

• Age: 60 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual has completed IRB 7489
• Diagnosed with DSM 5 MDD
• HRSD \>=18
• Willing to and capable of providing informed consent and complying with study procedures.

You may not qualify if:

• History of allergic or adverse reaction to
• Non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) and duloxetine (at least 4 weeks at dose of 60mg)during the current episode.
• Current treatment with psychotherapy, antidepressants, or other psychotropic medications.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Interventions

Escitalopram; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study had a planned accrual of 25 participants but only accrued 1 participant due to challenges in recruiting during the pandemic.

Results Point of Contact

• Title: Dr. Bret Rutherford
• Organization: New York State Psychiatric Institute

bret.rutherford@nyspi.columbia.edu

646-774-8660

Study Officials

• Bret R Rutherford, MD

  New York State Psychiatric Institue

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: March 3, 2021
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: May 11, 2022
• Results First Posted: March 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)