Clinical trial NCT00086190: Study of Antidepressants in Parkinson's Disease
Official title: Study of Antidepressants in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Depression
Keywords: Parkinson disease
depression
Parkinson's disease
paroxetine
venlafaxine
antidepressant
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2004-06-29
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Detailed description: Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.

The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.

This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.

Eligibility criteria: Inclusion Criteria:

To be eligible you must be:

* 30 years old or older
* diagnosed with Parkinson's disease
* experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HAM-D) Scores
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Beck Depression Inventory II (BDI-II)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Geriatric Depression Rating Scale (GDS)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Brief Psychiatric Rating Scale (BPRS)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Snaith Clinical Anxiety Scale (CAS)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Short Form 36 Health Survey - Mental Component Summary
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Short Form 36 Health Survey - Vitality
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Short Form 36 Health Survey - Role-Emotional
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
measure: Change in Short Form 36 Health Survey - Mental Health
timeFrame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Memphis
country: United States
facility: University of Tennessee-Memphis
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine, 6550 Fannin, Suite 1801
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: London
country: Canada
facility: London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
state: Ontario
city: Montreal
country: Canada
facility: Hotel-Dieu Hospital-CHUM
state: Quebec
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: University of Rochester
name: Irene Richard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Principal Investigator--Emory University School of Medicine
name: William McDonald, MD
role: PRINCIPAL_INVESTIGATOR
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