Vilazodone for Treatment of Geriatric Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01608295
First received: May 25, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: Vilazodone; Viibryd
Drug: Paroxetine; Paxil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: Each visit for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UKU Side-effect Profile [ Time Frame: Each visit for 12 weeks ] [ Designated as safety issue: No ]
  • Neurocognitive Measures [ Time Frame: Baseline and Final Visit ] [ Designated as safety issue: No ]
    A battery of neuropsychological tests

  • Inflammatory Biomarkers [ Time Frame: Baseline and Final Visit ] [ Designated as safety issue: No ]
    Blood Tests


Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 60 years of age or older
  • The presence of a major depressive disorder diagnosed according to the DSM-IV criteria
  • A 24-item Hamilton Rating Scale for Depression (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 MCI/ dementia; those with known allergic reactions to paroxetine or vilazodone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608295

Contacts
Contact: Natalie St. Cyr, M.A. 310-983-3375 nstcyr@mednet.ucla.edu

Locations
United States, California
UCLA Semel Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Natalie St. Cyr, M.A.    310-983-3375    nstcyr@mednet.ucla.edu   
Principal Investigator: Helen Lavretsky, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Forest Laboratories
Investigators
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles
  More Information

Additional Information:
No publications provided

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
Study First Received: May 25, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Mental Disorders
Mood Disorders
Antidepressive Agents
Paroxetine
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014