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Vilazodone for Treatment of Geriatric Depression

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ClinicalTrials.gov Identifier: NCT01608295
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : May 9, 2017
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles

Brief Summary:
The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vilazodone; Viibryd Drug: Paroxetine; Paxil Phase 4

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  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
Study Start Date : July 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


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.
Drug: Vilazodone; Viibryd
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:
  • Vilazodone
  • Viibryd
  • Antidepressant
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.
Drug: Paroxetine; Paxil
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:
  • Paroxetine
  • Paxil
  • Antidepressant



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. UKU Side-effect Profile [ Time Frame: Each visit for 12 weeks ]
    Number of participants with each side-effect event.

  2. Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test [ Time Frame: Baseline and Final Visit ]
    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.

  3. Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks) [ Time Frame: Baseline and Final Visit ]
    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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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608295


Locations
United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Forest Laboratories
Investigators
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles

Additional Information:
Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01608295     History of Changes
Other Study ID Numbers: VII-IT-02
First Posted: May 31, 2012    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: May 10, 2018
Last Verified: April 2018

Keywords provided by Helen Lavretsky, MD, University of California, Los Angeles:
depressed
geriatric
older adults
antidepressants
depression
anxious
major depressive disorder
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Paroxetine
Vilazodone Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists