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Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Daniel Weintraub, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00304161
First received: March 15, 2006
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depressive Disorder
Parkinson Disease
Interventions: Drug: Atomoxetine
Drug: Placebo

  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 from The Parkinson's Disease and Movement Disorders Center at Pennsylvania Hospital and the Parkinson's Disease Research, Education, and Clinical Center at the Philadelphia Veterans Affairs Medical Center between 2004-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine Participants will receive 40-80mgs of atomoxetine orally once daily.
Placebo Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

Participant Flow:   Overall Study
    Atomoxetine     Placebo  
STARTED     28     27  
COMPLETED     22     21  
NOT COMPLETED     6     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine Participants will receive atomoxetine treatment
Placebo Participants will receive placebo treatment
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  28     27     55  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     11     25  
>=65 years     14     16     30  
Age  
[units: years]
Mean (Standard Deviation)
  63.8  (9.5)     64.9  (11.5)     64.3  (10.5)  
Gender  
[units: participants]
     
Female     8     11     19  
Male     20     16     36  
Region of Enrollment  
[units: participants]
     
United States     28     27     55  



  Outcome Measures
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1.  Primary:   Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale   [ Time Frame: Week 8 ]

2.  Secondary:   Clinical Global Impression-Improvement Scale   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
First, the sample size was relatively small. Second, the diagnostic criteria for depression which are typically used in clinical trials were not used as an inclusion criterion. Third, antidepressant use at baseline was common in our population.


  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.


Results Point of Contact:  
Name/Title: Dr. Daniel Weintraub
Organization: University of Pennsylvania
phone: 215-349-8207
e-mail: daniel.weintraub@uphs.upenn.edu


Publications of Results:

Responsible Party: Daniel Weintraub, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00304161     History of Changes
Other Study ID Numbers: K23MH067894 ( US NIH Grant/Contract Award Number )
Study First Received: March 15, 2006
Results First Received: June 12, 2012
Last Updated: March 10, 2015
Health Authority: United States: Federal Government