Study of Antidepressants in Parkinson's Disease (SAD-PD)

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease; Depression

Treatments: Other: placebo; Drug: paroxetine; Drug: venlafaxine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00086190

R01NS046487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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115 participants in 3 patient groups, including a placebo group

paroxetine

Active Comparator group

Description:

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Treatment:

Drug: paroxetine

venlafaxine extended release

Active Comparator group

Description:

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Treatment:

Drug: venlafaxine

placebo

Placebo Comparator group

Description:

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Treatment:

Other: placebo