Completed
SAD-PD

Study of Antidepressants in Parkinson's Disease

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What is being tested

paroxetine

+ venlafaxine
+ placebo
Drug
Other
Who is being recruted

Parkinson Disease

+ Depression
Over 30 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: June 2005

See protocol details

Summary

Principal SponsorUniversity of Rochester
Last updated: January 4, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2005Actual date on which the first participant was enrolled.

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. 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 TitleStudy of Antidepressants in Parkinson's Disease 
Principal SponsorUniversity of Rochester
Last updated: January 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
115 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 30 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Parkinson Disease
Depression
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Group II
Active Comparator
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Group III
Placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Study Objectives
Primary Objectives

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 Objectives

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.

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.

Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.

Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.

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.

Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.

Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.

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.

Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.

Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.

Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.

Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.

Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.

Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.

Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.

Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 18 locations
Suspended
University of California San FranciscoSan Francisco, United StatesSee the location
Suspended
University of FloridaGainesville, United States
Suspended
University of MiamiMiami, United States
Suspended
Emory University School of MedicineAtlanta, United States
Completed18 Study Centers