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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304161
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : March 13, 2015
Last Update Posted : January 30, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depressive Disorder
Parkinson Disease
Interventions: Drug: Atomoxetine
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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

Baseline Measures
   Atomoxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   27   55 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14  50.0%      11  40.7%      25  45.5% 
>=65 years      14  50.0%      16  59.3%      30  54.5% 
[Units: Years]
Mean (Standard Deviation)
 63.8  (9.5)   64.9  (11.5)   64.3  (10.5) 
[Units: Participants]
Count of Participants
Female      8  28.6%      11  40.7%      19  34.5% 
Male      20  71.4%      16  59.3%      36  65.5% 
Region of Enrollment 
[Units: Participants]
United States   28   27   55 

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: University of Pennsylvania Identifier: NCT00304161     History of Changes
Other Study ID Numbers: K23MH067894 ( U.S. NIH Grant/Contract )
K23MH067894 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: June 12, 2012
Results First Posted: March 13, 2015
Last Update Posted: January 30, 2017