Study of Antidepressants in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Antidepressants in Parkinson's Disease

Conditions
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Parkinson Disease, Depression

Intervention / Treatment
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* Drug: paroxetine
* Drug: venlafaxine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paroxetine<br>Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | Drug: paroxetine<br>* 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.<br>* Other names: Paxil;|
| Active Comparator: venlafaxine extended release<br>Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | Drug: venlafaxine<br>* 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.<br>* Other names: Effexor XR;|
| Placebo Comparator: placebo<br>Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | Other: placebo<br>* an inactive substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale (HAM-D) Scores | Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Beck Depression Inventory II (BDI-II) | Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Geriatric Depression Rating Scale (GDS) | Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Brief Psychiatric Rating Scale (BPRS) | Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) | Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Snaith Clinical Anxiety Scale (CAS) | Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar | Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall | Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being | Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Short Form 36 Health Survey - Mental Component Summary | Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Short Form 36 Health Survey - Vitality | Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Short Form 36 Health Survey - Role-Emotional | Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 
| Change in Short Form 36 Health Survey - Mental Health | Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant