Back to resultsVilazodone for Treatment of Geriatric Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vilazodone; Viibryd
Paroxetine; Paxil
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depressed, geriatric, older adults, antidepressants, depression, anxious, major depressive disorder, MDD
Eligibility Criteria
Inclusion Criteria:
- 60 years of age or older
- The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
- Mini-Mental State Exam (MMSE) score > 24.
Exclusion Criteria:
- Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.
Sites / Locations
- UCLA Semel Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vilazodone; Viibryd
Paroxetine; Paxil
Arm Description
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale (HDRS)
The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Secondary Outcome Measures
UKU Side-effect Profile
Number of participants with each side-effect event.
Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.
Full Information
NCT ID
NCT01608295
First Posted
May 25, 2012
Last Updated
April 12, 2018
Sponsor
University of California, Los Angeles
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01608295
Brief Title
Vilazodone for Treatment of Geriatric Depression
Official Title
A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.
Detailed Description
This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depressed, geriatric, older adults, antidepressants, depression, anxious, major depressive disorder, MDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vilazodone; Viibryd
Arm Type
Experimental
Arm Description
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Arm Title
Paroxetine; Paxil
Arm Type
Experimental
Arm Description
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Intervention Type
Drug
Intervention Name(s)
Vilazodone; Viibryd
Other Intervention Name(s)
Vilazodone, Viibryd, Antidepressant
Intervention Description
Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
Intervention Type
Drug
Intervention Name(s)
Paroxetine; Paxil
Other Intervention Name(s)
Paroxetine, Paxil, Antidepressant
Intervention Description
Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Description
The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
UKU Side-effect Profile
Description
Number of participants with each side-effect event.
Time Frame
Each visit for 12 weeks
Title
Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
Description
The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.
Time Frame
Baseline and Final Visit
Title
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
Description
Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.
Time Frame
Baseline and Final Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 years of age or older
The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
Mini-Mental State Exam (MMSE) score > 24.
Exclusion Criteria:
Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lavretsky, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.semel.ucla.edu/latelife
Description
Double-blind comparison of vilazodone to paroxetine in geriatric depression
Learn more about this trial
Vilazodone for Treatment of Geriatric Depression
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