Treatment of Depression in Parkinson's Disease Trial
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|ClinicalTrials.gov Identifier: NCT00062738|
Recruitment Status : Completed
First Posted : June 13, 2003
Results First Posted : March 5, 2013
Last Update Posted : November 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Depression||Drug: paroxetine Drug: Nortriptyline Other: placebo||Phase 2|
Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.
Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.
A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Depression in Patients With Parkinson's Disease|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
nortriptyline 25 - 75 mg q hs
Other Name: Pamelor
Paroxetine CR 12.5 - 25 mg q hs
Other Name: Paxil CR
Placebo Comparator: placebo
- Hamilton Depression Scale [ Time Frame: 8 weeks ]total score on HDRS (0-54 higher score is worse)
- Percent Responders [ Time Frame: 8 weeks ]Percent of patients who had a 50% decrease in total HDRS at 8 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062738
|United States, New Jersey|
|Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Matthew Menza, M.D.||Rutgers, The State University of New Jersey|