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

Brief Summary:
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Depressive Disorder Parkinson Disease Drug: Atomoxetine Drug: Placebo Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression Diagnosis and Treatment in Parkinson Disease
Study Start Date : July 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Atomoxetine
Participants will receive 40-80mgs of atomoxetine orally once daily.
Drug: Atomoxetine
40 to 80 mg orally once daily for 8 weeks
Other Name: Straterra
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.
Drug: Placebo
40 to 80 mg orally once daily for 8 weeks

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

Secondary Outcome Measures :
  1. Clinical Global Impression-Improvement Scale [ Time Frame: Week 8 ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00304161

United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Daniel Weintraub, MD University of Pennsylvania

Additional Information:
Publications of Results:
Responsible Party: University of Pennsylvania Identifier: NCT00304161     History of Changes
Other Study ID Numbers: K23MH067894 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2006    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: January 30, 2017
Last Verified: December 2016

Keywords provided by University of Pennsylvania:
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Depressive Disorder
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mood Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs