Predictors of Cognitive Outcomes in Geriatric Depression

NCT05273996 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: IE-13-048H-6.1R01MH108578
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on examining effects of stress on long-term mood and cognitive outcomes of late-life depression. It will also example the neural underpinnings of these changes using structural and functional brain imaging. Understanding how effects of stress in older depressed adults, as well as factors that might minimize those effects, lead to particular mood and cognitive outcomes will inform future development of novel prevention strategies.

Conditions

Major Depressive Disorder; Neuroticism; Cognitive Change; Stress

Keywords

Late Life Depression

Outcome Measures

Primary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRAS)

  Measure of depression severity and Recurrence of Depression Minimum Score = 0; Maximum Score = 60; Higher score means worse outcome

  Three years

• Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery Total Score

  Global cognitive measure; Minimum Score = 0; Maximum Score = 100; Higher score means better outcome

  Three years

• Cognitive clinical diagnosis

  Participant records will be reviewed annually by the consensus panel. The study will convene a panel of experts to review each case, including the PI, treating geriatric psychiatrists and study neuropsychologist. Panel members review the following information for each participant: 1) initial evaluation and most recent clinical depression study notes, 2) neuropsychological testing profiles, 3) informant report of cognitive decline based on the Dementia Severity Rating Scale, 4) study structural MRI images to determine vascular burden, and 5) additional neurological and clinical neuropsychological consultations when available. The panel discusses the case until a consensus cognitive diagnosis is reached.

  three years

Secondary Outcomes (2)

• Functional brain magnetic resonance imaging (fMRI) scan changes in resting state functional connectivity.

  Two years

• Functional brain magnetic resonance imaging (fMRI) scan structural imaging changes

  Two years

Other Outcomes (1)

• Neuroticism subtest score on NEO Personality Inventory

  Three years

Study Arms (1)

Depressed

OTHER

Subjects receive FDA-approved antidepressants

Drug: Sertraline, bupropion, desvenlafaxine

Interventions

Sertraline, bupropion, desvenlafaxine DRUG

Study geriatric psychiatrists prescribe FDA-approved antidepressants using a treatment algorithm consistent with the STAGED (Duke Somatic Treatment Algorithm for Geriatric Depression) approach, with standardization of treatment in the first six months beginning with sertraline, with the option of augmentation with bupropion or switch to desvenlafaxine. Beyond six months of acute treatment, subjects are treated based on the study psychiatrist's clinical assessment and recommendations, consistent with STAGED guidelines.

Also known as: Zoloft, Wellbutrin, Pristiq

Depressed

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• major depression, single episode or recurrent;
• ability to read and write English;
• Mini-Mental State Examination \>25.

You may not qualify if:

• lifetime alcohol/drug dependence
• conditions associated with brain abnormalities such hydrocephalus, benign and cancerous brain tumors, epilepsy, Parkinson's disease, Huntington's chorea, dementia, demyelinating diseases, etc.
• untreated endocrine disorder other than diabetes mellitus
• established clinical diagnosis of dementia
• other primary psychiatric disorders, e.g., panic disorder, social phobia, obsessive- compulsive disorder, schizoaffective disorder, schizophrenia, bipolar disorder

Sponsors & Collaborators

• David Steffens: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline; Bupropion; Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Phenols; Benzene Derivatives; Lipids

Study Officials

• David Steffens, M.D., M.H.S.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Samuel "Sy" Birnbaum/Ida, Louis and Richard Blum Chair in Psychiatry Professor and Chair, Department of Psychiatry

Model Details: Naturalistic study using FDA approved antidepressants to examine the effects of stress and neuroticism on outcomes

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 10, 2022
• Study Start: September 28, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: Potential investigators will gain knowledge of the project through NIH Reporter and through Dr. Steffens' UConn webpage. They will be able to contact Dr. Steffens and he will work with the investigator to determine the nature of what the investigator wishes to study to ensure that he/she has a complete data set that will allow for a successful analysis. Dr. Steffens' team will create an anonymized data set, encrypt it, and electronically transfer it to the investigator. Dr. Steffens will maintain a list of approved analyses and track progress of manuscripts and publications. In addition, consistent with National Institute of Mental Health (NIMH)requirements, Dr. Steffens will plan to submit data via the NIMH Data Archive (NDA).

Locations

US (1)