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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Irene Richard, University of Rochester
ClinicalTrials.gov Identifier:
NCT00086190
First received: June 28, 2004
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Depression
Drug: paroxetine
Drug: venlafaxine
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Antidepressants in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale (HAM-D) Scores [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: Yes ]
    Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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) [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase ] [ Designated as safety issue: No ]
    Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.


Enrollment: 115
Study Start Date: June 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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.
Other Name: Paxil
Active Comparator: venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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 Name: Effexor XR
Placebo Comparator: placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Other: placebo
an inactive substance

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086190

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
University of Maryland
Baltimore, Maryland, United States, 21250
United States, Massachusetts
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester
Rochester, New York, United States, 14627
United States, Ohio
Medical University of Ohio
Toledo, Ohio, United States
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Tennessee
University of Tennessee-Memphis
Memphis, Tennessee, United States, 38163
United States, Texas
Baylor College of Medicine, 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22901
Canada, Ontario
London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada, H2W 1T8
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Irene Richard, MD University of Rochester
Principal Investigator: William McDonald, MD Co-Principal Investigator--Emory University School of Medicine
  More Information

Publications:
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994.

Responsible Party: Irene Richard, Irene Richard, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00086190     History of Changes
Other Study ID Numbers: R01NS046487
Study First Received: June 28, 2004
Results First Received: January 11, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Parkinson disease
depression
Parkinson's disease
paroxetine
venlafaxine
antidepressant

Additional relevant MeSH terms:
Depressive Disorder
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mood Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Depression
Behavioral Symptoms
Antidepressive Agents
Paroxetine
Venlafaxine
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014