Study of Antidepressants in Parkinson's Disease

Depression Clinical Trial

— SAD-PD  

Official title:

Study of Antidepressants in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086190
• Other study ID #: R01NS046487
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2004
• Last updated: January 3, 2013
• Start date: June 2005
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Parkinson Disease

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road	London	Ontario
Canada	Hotel-Dieu Hospital-CHUM	Montreal	Quebec
Puerto Rico	University of Puerto Rico	San Juan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine, 6550 Fannin, Suite 1801	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	University of Tennessee-Memphis	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	University of California San Francisco	San Francisco	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Medical University of Ohio	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No