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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

March 15, 2006
March 10, 2015
July 2004
December 2008   (final data collection date for primary outcome measure)
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.
Change in score on the IDS scale (measured at Week 8)
Complete list of historical versions of study NCT00304161 on ClinicalTrials.gov Archive Site
Clinical Global Impression-Improvement Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:

  1. = Very much improved
  2. = Much improved
  3. = Minimally improved
  4. = No change
  5. = Minimally worse
  6. = Much worse
  7. = Very much worse

A participant scoring a 1 or 2 is considered a responder on the CGI scale.

Score on the CGI-I scale (measured at Week 8)
Not Provided
Not Provided
 
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Depression Diagnosis and Treatment in Parkinson Disease
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Disorder
  • Parkinson Disease
  • Drug: Atomoxetine
    40 to 80 mg orally once daily for 8 weeks
    Other Name: Straterra
  • Drug: Placebo
    40 to 80 mg orally once daily for 8 weeks
  • Active Comparator: Atomoxetine
    Participants will receive 40-80mgs of atomoxetine orally once daily.
    Intervention: Drug: Atomoxetine
  • Placebo Comparator: Placebo
    Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
    Intervention: Drug: Placebo
Weintraub D, Mavandadi S, Mamikonyan E, Siderowf AD, Duda JE, Hurtig HI, Colcher A, Horn SS, Nazem S, Ten Have TR, Stern MB. Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease. Neurology. 2010 Aug 3;75(5):448-55. doi: 10.1212/WNL.0b013e3181ebdd79.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease
  • IDS score greater than 21
  • Mini-Mental State Examination (MMSE) score greater than 15

Exclusion Criteria:

  • Recent deep brain stimulation
  • Currently participating in an antidepressant trial at a less than adequate dose and duration
  • Severe depression or depression with suicide ideation
  • History of liver toxicity
  • Unstable medical disease or comorbid psychiatric disease
Both
30 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00304161
K23MH067894, K23MH067894
No
Not Provided
Not Provided
Daniel Weintraub, University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Daniel Weintraub, MD University of Pennsylvania
University of Pennsylvania
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP