Official Title: “Study of Antidepressants in Parkinson's Disease”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: paroxetine
  • Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
• Drug: venlafaxine
  • Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
• Other: placebo
  • an inactive substance

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: paroxetine
  • Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
• Active Comparator: venlafaxine extended release
  • Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
• Placebo Comparator: placebo
  • Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Primary Measures

• change in HAM-D scores
  • Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
    Safety Issue?: No

Secondary Measures

• Montgomery-Asberg Depression Rating Scale (MADRS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Beck Depression Inventory II (BDI-II)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Geriatric Depression Rating Scale (GDS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Clinical Global Impression (CGI)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Adverse Experiences
  • Time Frame: 12 weeks (collected at every visit)
    Safety Issue?: Yes
• Vital Signs
  • Time Frame: 12 weeks (done at every visit)
    Safety Issue?: Yes
• Telephone Contact to Assess Suicidality
  • Time Frame: Done at Week 10 and Week 14
    Safety Issue?: Yes
• Brief Psychiatric Rating Scale (BPRS)
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• UKU Side Effect rating Scale
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Unified Parkinson's Disease Rating Scale (UPDRS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Schwab and England ADL Scale
  • Time Frame: 12 weeks
    Safety Issue?: No
• Cognitive Test Battery
  • Time Frame: Done at Baseline and Week 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Rochester

Overall Clinical Trial Officials and Contacts

Irene Richard, MD Principal Investigator University of Rochester  

Overall Contact: Nancy Pearson, RN, MS 585-273-2982 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00086190

Study ID Number: R01NS046487

ClinicalTrials.gov Identifier: NCT00086190

Health Authority: United States: Food and Drug Administration