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Treatment of Depression in Parkinson's Disease Trial

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00062738
First received: June 12, 2003
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
Results First Received: December 5, 2012  
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
Conditions: Parkinson Disease
Depression
Interventions: Drug: paroxetine
Drug: Nortriptyline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between 10/2003 and 7/2007, from the RWJMS movement disorder clinic and advertising to local support groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who met inclusion and not exclusion criteria were enrolled.

Reporting Groups
  Description
Nortriptyline Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
Paroxetine Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
Placebo Placebo was started at 1 pill and could be increased up to three pills.

Participant Flow:   Overall Study
    Nortriptyline     Paroxetine     Placebo  
STARTED     17     18     17  
COMPLETED     17     18     17  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Nortriptyline Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
Paroxetine Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
Placebo Placebo was started at 1 pill and could be increased up to three pills.
Total Total of all reporting groups

Baseline Measures
    Nortriptyline     Paroxetine     Placebo     Total  
Number of Participants  
[units: participants]
 		  17     18     17     52  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     10     11     31  
>=65 years     7     8     6     21  
Age  
[units: years]
Mean ± Standard Deviation 		  62.9  ± 9.3     62.8  ± 8.1     61.4  ± 9.2     62.2  ± 8.7  
Gender  
[units: participants]
 		       
Female     11     5     9     25  
Male     6     13     8     27  
Region of Enrollment  
[units: participants]
 		       
United States     17     18     17     52  



  Outcome Measures
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1.  Primary:   Hamilton Depression Scale   [ Time Frame: 8 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percent Responders   [ Time Frame: 8 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was only an eight week trial with relatively few participants.  


Results Point of Contact:  
Name/Title: Matthew Menza, MD
Organization: UMDNJ - RWJMS
phone: 732-235-4440
e-mail: menza@umdnj.edu


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00062738     History of Changes
Other Study ID Numbers: 4381
Study First Received: June 12, 2003
Results First Received: December 5, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government