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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

Tracking Information
First Submitted Date  ICMJE May 25, 2012
First Posted Date  ICMJE May 31, 2012
Results First Submitted Date  ICMJE February 1, 2017
Results First Posted Date  ICMJE May 9, 2017
Last Update Posted Date May 10, 2018
Study Start Date  ICMJE July 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: Each visit for 12 weeks ]
Change History Complete list of historical versions of study NCT01608295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • UKU Side-effect Profile [ Time Frame: Each visit for 12 weeks ]
    Number of participants with each side-effect event.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • UKU Side-effect Profile [ Time Frame: Each visit for 12 weeks ]
  • Neurocognitive Measures [ Time Frame: Baseline and Final Visit ]
    A battery of neuropsychological tests
  • Inflammatory Biomarkers [ Time Frame: Baseline and Final Visit ]
    Blood Tests
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vilazodone for Treatment of Geriatric Depression
Official Title  ICMJE A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vilazodone; Viibryd
  • 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.
    Intervention: Drug: Paroxetine; Paxil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2015)
65
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2012)
80
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608295
Other Study ID Numbers  ICMJE VII-IT-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helen Lavretsky, MD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP