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

Primary Purpose

Parkinson Disease, Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
paroxetine
venlafaxine
placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco
  • University of Florida
  • University of Miami
  • Emory University School of Medicine
  • University of Kentucky
  • Johns Hopkins University
  • University of Maryland
  • Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
  • Washington University School of Medicine
  • University of Rochester
  • Medical University of Ohio
  • Oregon Health Sciences University
  • University of Tennessee-Memphis
  • Baylor College of Medicine, 6550 Fannin, Suite 1801
  • University of Virginia
  • London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
  • Hotel-Dieu Hospital-CHUM
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

paroxetine

venlafaxine extended release

placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Change in Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
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.
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.
Change in Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 28, 2004
Last Updated
January 3, 2013
Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00086190
Brief Title
Study of Antidepressants in Parkinson's Disease
Acronym
SAD-PD
Official Title
Study of Antidepressants in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression
Keywords
Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paroxetine
Arm Type
Active Comparator
Arm Description
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Arm Title
venlafaxine extended release
Arm Type
Active Comparator
Arm Description
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Intervention Type
Drug
Intervention Name(s)
paroxetine
Other Intervention Name(s)
Paxil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Other Intervention Name(s)
Effexor XR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HAM-D) Scores
Description
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.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Secondary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Beck Depression Inventory II (BDI-II)
Description
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.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Geriatric Depression Rating Scale (GDS)
Description
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Brief Psychiatric Rating Scale (BPRS)
Description
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Snaith Clinical Anxiety Scale (CAS)
Description
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
Description
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.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Description
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Description
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Description
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
Description
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Short Form 36 Health Survey - Mental Component Summary
Description
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Short Form 36 Health Survey - Vitality
Description
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Short Form 36 Health Survey - Role-Emotional
Description
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Title
Change in Short Form 36 Health Survey - Mental Health
Description
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time Frame
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Richard, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William McDonald, MD
Organizational Affiliation
Co-Principal Investigator--Emory University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21250
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Medical University of Ohio
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Tennessee-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Baylor College of Medicine, 6550 Fannin, Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Hotel-Dieu Hospital-CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

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Study of Antidepressants in Parkinson's Disease

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