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Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression

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ClinicalTrials.gov Identifier: NCT01896934
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Warren Taylor, Vanderbilt University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Major Depressive Disorder
Intervention Drug: Sertraline
Enrollment 31
Recruitment Details  
Pre-assignment Details Participants taking ineffective antidepressant medications underwent a washout period. 10 recruited individuals were withdrawn after screening for a) concomitant medications (N=2), b) depression not severe (N=4), c) MRI contraindications (N=4)
Arm/Group Title Sertraline
Hide Arm/Group Description

50-200mg daily

Sertraline: 50-200mg daily

Period Title: Overall Study
Started 21
Completed 19
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Sertraline
Hide Arm/Group Description 50-200mg daily
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  38.1%
>=65 years
13
  61.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
68.05  (7.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
13
  61.9%
Male
8
  38.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
21
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   9.5%
White
18
  85.7%
More than one race
1
   4.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
Montgomery-Asberg Depression Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 21 participants
27.43  (4.80)
[1]
Measure Description: Depression rating scale, clinician rated, range 0-60, where higher scores indicate more severe depression
Quick Inventory of Depressive Symptoms   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants
11.94  (4.5)
[1]
Measure Description: Depression rating scale, self-report, Range 0-27, where higher scores indicate more severe depression
[2]
Measure Analysis Population Description: Baseline data missing for 4 individuals (3 subject did not complete, 1 deviation where questionnaire was not provided to subject)
1.Primary Outcome
Title Remission of Depression
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals achieving remission of depression, defined as MADRS score of 7 or less.
Arm/Group Title Sertraline
Hide Arm/Group Description:

50-200mg daily

Sertraline: 50-200mg daily

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
2.Secondary Outcome
Title Change in Clinician-rated Depression Severity
Hide Description Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression
Time Frame Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline
Hide Arm/Group Description:

50-200mg daily

Sertraline: 50-200mg daily

Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.14  (9.84)
3.Secondary Outcome
Title Change in Patient-rated Depression Severity
Hide Description Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression.
Time Frame Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline
Hide Arm/Group Description:

50-200mg daily

Sertraline: 50-200mg daily

Overall Number of Participants Analyzed 17
Mean (Standard Error)
Unit of Measure: units on a scale
3.82  (6.04)
Time Frame 12 weeks
Adverse Event Reporting Description

Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions.

Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.

 
Arm/Group Title Sertraline
Hide Arm/Group Description 50-200mg daily
All-Cause Mortality
Sertraline
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sertraline
Affected / at Risk (%)
Total   14/21 (66.67%) 
Eye disorders   
Vision changes *  1/21 (4.76%) 
Dry Eyes *  1/21 (4.76%) 
Gastrointestinal disorders   
Nausea *  1/21 (4.76%) 
Constipation *  1/21 (4.76%) 
Dry Mouth *  2/21 (9.52%) 
General disorders   
Fatigue *  3/21 (14.29%) 
Infections and infestations   
Upper Respiratory Infection *  2/21 (9.52%) 
Musculoskeletal and connective tissue disorders   
Muscle cramps *  1/21 (4.76%) 
Nervous system disorders   
Vivid Dreams *  1/21 (4.76%) 
Headache *  3/21 (14.29%) 
Tremor *  1/21 (4.76%) 
Reproductive system and breast disorders   
Sexual Dysfunction *  2/21 (9.52%) 
*
Indicates events were collected by non-systematic assessment
Limitations include a small sample that reflects this is a pharmacoimaging study using MRI to examine imaging findings related to antidepressant treatment outcomes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Warren D Taylor
Organization: Vanderbilt University Medical Center
Phone: 615-936-3555
EMail: warren.d.taylor@vanderbilt.edu
Layout table for additonal information
Responsible Party: Warren Taylor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01896934     History of Changes
Other Study ID Numbers: 130360
R21MH099218-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 1, 2013
First Posted: July 11, 2013
Results First Submitted: May 16, 2017
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017