Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression

NCT01896934 | Completed Phase 4 Results

• 2 other identifiers: 130360R21MH099218-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this line of research is to determine if decreased vascular reactivity and frontal hypoperfusion is associated with poor response antidepressants. Such perfusion deficits could contribute to antidepressant nonresponse as they would hinder improvements in dorsal system metabolism seen with antidepressant treatment. The objective of the current proposal is to determine if decreased vascular reactivity and frontal hypoperfusion in depressed elders predicts and persists with antidepressant nonremission. The investigators will pursue the primary aim testing the hypothesis that decreased reactivity and hypoperfusion, specifically in the dorsolateral prefrontal cortex and dorsal anterior cingulate cortex, predict antidepressant nonremission. The investigators will enroll 40 depressed elders who will complete clinical, cognitive, and MRI assessments before and after a 12-week open-label antidepressant trial of sertraline.

Conditions

Major Depressive Disorder

Keywords

Depression; Antidepressants; Elderly; Geriatrics

Outcome Measures

Primary Outcomes (1)

• Remission of Depression

  Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.

  Week 12

Secondary Outcomes (2)

• Change in Clinician-rated Depression Severity

  Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

• Change in Patient-rated Depression Severity

  Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

Study Arms (1)

Sertraline

EXPERIMENTAL

50-200mg daily

Drug: Sertraline

Interventions

Sertraline DRUG

50-200mg daily

Also known as: Zoloft

Sertraline

Eligibility Criteria

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

You may qualify if:

• Age 60 years or older.
• Current diagnosis of major depressive disorder (DSM-IV-TR), single episode, recurrent or chronic, without psychotic features, as detected by MINI and clinical exam.
• Minimum MADRS score ≥ 15.
• Mini-Mental State Exam ≥ 22.
• Ability to read and write English.

You may not qualify if:

• Current or past diagnoses of other Axis I psychiatric disorders, including panic disorder and substance dependence.
• Any use of illicit substances (such as marijuana or cocaine) or abuse of prescription medications (such as benzodiazepines or opiates) within the last three months.
• Presence of acute suicidality
• Current or past psychosis
• Known primary neurological disorder, including dementia, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
• Chronic untreated medical disorders (including but not limited to hypertension, hyperlipidemia, fibromyalgia, hypothyroidism, or any other disorder) where treatment is warranted
• Need for continuous oxygen use or any medical disorder where the hypercapnia challenge would be contraindicated or put the subject at increased risk. This would include active respiratory disease, chronic angina or other unstable cardiac conditions.
• Any physical or intellectual disability affecting completion of assessments
• MRI contraindications
• Electroconvulsive therapy in last 6 months
• Use of fluoxetine in the last 6 weeks. Occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during the last month is allowable.
• Known allergy or hypersensitivity to sertraline
• A failed therapeutic trial of sertraline in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 100mg or higher)
• Current or planned psychotherapy

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Limitations include a small sample that reflects this is a pharmacoimaging study using MRI to examine imaging findings related to antidepressant treatment outcomes.

Results Point of Contact

• Title: Dr. Warren D Taylor
• Organization: Vanderbilt University Medical Center

warren.d.taylor@vanderbilt.edu

615-936-3555

Study Officials

• Warren D Taylor, MD, MHSc

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-06

Locations

US (1)