- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01608295
Vilazodone for Treatment of Geriatric Depression
April 12, 2018 updated by: Helen Lavretsky, MD, University of California, Los Angeles
A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90095
- UCLA Semel Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vilazodone; Viibryd
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.
|
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.
Other Names:
|
Experimental: Paroxetine; Paxil
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Depression Rating Scale (HDRS)
Time Frame: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UKU Side-effect Profile
Time Frame: Each visit for 12 weeks
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Number of participants with each side-effect event.
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Each visit for 12 weeks
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Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
Time Frame: Baseline and Final Visit
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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.
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Baseline and Final Visit
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Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
Time Frame: Baseline and Final Visit
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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.
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Baseline and Final Visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Helen Lavretsky, M.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
May 25, 2012
First Submitted That Met QC Criteria
May 25, 2012
First Posted (Estimate)
May 31, 2012
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
April 12, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Paroxetine
- Vilazodone Hydrochloride
- Antidepressive Agents
Other Study ID Numbers
- VII-IT-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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