Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

NCT01973283 | Completed Phase 4 Results

• 2 other identifiers: #6470/7289RK23MH099097-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) \> 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).

Conditions

Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder, NOS

Outcome Measures

Primary Outcomes (7)

• Hamilton Rating Scale for Depression (HRSD)

  Measure Description: 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.

  Week 8

• Hamilton Rating Scale for Depression (HRSD)

  Measure Description: 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.

  6 Months

• Hamilton Depression Rating Scale (HRSD)

  Measure Description: 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.

  12 Months

• Hamilton Depression Rating Scale: Stratified by Baseline Frailty

  Measure Description: 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.

  Baseline (Week 0)

• Hamilton Depression Rating Scale: Stratified by Baseline Frailty

  Measure Description: 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.

  Week 8

• Hamilton Depression Rating Scale: Stratified by Baseline Frailty

  Measure Description: 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.

  Month 6

• Hamilton Depression Rating Scale: Stratified by Baseline Frailty

  Measure Description: 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.

  Month 12

Secondary Outcomes (8)

• World Health Organization Disability Assessment 2.0 (36-item)

  Baseline (Week 0)

• World Health Organization Disability Assessment 2.0 (36-item)

  Week 8

• World Health Organization Disability Assessment 2.0 (36-item)

  6 Months

• World Health Organization Disability Assessment 2.0 (36-item)

  12 Months

• World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty

  Baseline (Week 0)

Study Arms (1)

Medication Treatment

EXPERIMENTAL

Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.

Drug: Antidepressant Medication

Interventions

Antidepressant Medication DRUG

If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.

Also known as: Escitalopram, Duloxetine, Open treatment

Medication Treatment

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone with 1 or more characteristics of frailty
• HRSD\>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)
• Capable of providing informed consent
• Currently followed by a PCP (had an eval in last 6-months)

You may not qualify if:

• Acute cancer treatment
• Acute, severe or unstable medical illness
• End stage medical illness (e.g. liver, kidney, pulmonary)
• Mini Mental Exam \< 24 or a diagnosis of dementia
• Individuals who do not have capacity to consent
• Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine dependence
• History of psychosis or psychotic disorder or bipolar disorder
• Patient is considered a significant risk of suicide
• Subject is considered based on history to be unlikely to respond to the single agent antidepressant (i.e., subjects with treatment resistant depression, including subjects with previous treatment with ECT)
• History of allergic or adverse reaction to escitalopram or duloxetine, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine (at least 4 weeks at dose of 90mg).

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (5)

• Binder EF, Yarasheski KE, Steger-May K, Sinacore DR, Brown M, Schechtman KB, Holloszy JO. Effects of progressive resistance training on body composition in frail older adults: results of a randomized, controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Nov;60(11):1425-31. doi: 10.1093/gerona/60.11.1425.

  PMID: 16339329 BACKGROUND

• Brown M, Sinacore DR, Binder EF, Kohrt WM. Physical and performance measures for the identification of mild to moderate frailty. J Gerontol A Biol Sci Med Sci. 2000 Jun;55(6):M350-5. doi: 10.1093/gerona/55.6.m350.

  PMID: 10843356 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Brown PJ, Roose SP, O'Boyle KR, Ciarleglio A, Maas B, Igwe KC, Chung S, Gomez S, Naqvi M, Brickman AM, Rutherford BR. Frailty and Its Correlates in Adults With Late Life Depression. Am J Geriatr Psychiatry. 2020 Feb;28(2):145-154. doi: 10.1016/j.jagp.2019.10.005. Epub 2019 Oct 14.

  PMID: 31734083 RESULT

• Brown PJ, Ciarleglio A, Roose SP, Garcia CM, Chung S, Alvarez J, Stein A, Gomez S, Rutherford BR. Frailty Worsens Antidepressant Treatment Outcomes in Late Life Depression. Am J Geriatr Psychiatry. 2021 Sep;29(9):944-955. doi: 10.1016/j.jagp.2020.12.024. Epub 2020 Dec 25.

  PMID: 33388223 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Depression

Interventions

Antidepressive Agents; Escitalopram; Duloxetine Hydrochloride; Open Abdomen Techniques

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Abdominal Wound Closure Techniques; Wound Closure Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Patrick J Brown
• Organization: New York State Psychiatric Institute

patrick.brown@nyspi.columbia.edu

646-774-8666

Study Officials

• Patrick Brown, PhD

  New York State Psychiatric Institute

  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 Psychology (in Psychiatry)

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: February 19, 2014
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2020
• Last Updated: January 29, 2021
• Results First Posted: January 13, 2021

Record last verified: 2021-01

Locations

US (1)