Vilazodone for Treatment of Geriatric Depression

NCT01608295 | Completed Phase 4 Results DMC

• 1 other identifier: VII-IT-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

depressed; geriatric; older adults; antidepressants; depression; anxious; major depressive disorder; MDD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (3)

• UKU Side-effect Profile

  Each visit for 12 weeks

• Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test

  Baseline and Final Visit

• Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)

  Baseline and Final Visit

Study Arms (2)

Vilazodone; Viibryd

EXPERIMENTAL

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

Paroxetine; Paxil

EXPERIMENTAL

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

Interventions

Vilazodone; Viibryd DRUG

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.

Also known as: Vilazodone, Viibryd, Antidepressant

Vilazodone; Viibryd

Paroxetine; Paxil DRUG

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.

Also known as: Paroxetine, Paxil, Antidepressant

Paroxetine; Paxil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Forest Laboratories: collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Links

• Double-blind comparison of vilazodone to paroxetine in geriatric depression

MeSH Terms

Conditions

Depressive Disorder, Major; Consciousness Disorders; Depression; Anxiety Disorders

Interventions

Vilazodone Hydrochloride; Antidepressive Agents; Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Piperidines

Results Point of Contact

• Title: Helen Lavretsky, M.D.
• Organization: UCLA

hlavretsky@mednet.ucla.edu

310-794-4619

Study Officials

• Helen Lavretsky, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 11, 2018
• Results First Posted: May 9, 2017

Record last verified: 2018-04

Locations

US (1)