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Completed

NCT Number: NCT00304161

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

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

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Key information

Conditions

Depressive Disorder Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Mood Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine

Drug

40 to 80 mg orally once daily for 8 weeks

Other names: Straterra

Placebo

Drug

40 to 80 mg orally once daily for 8 weeks

Primary outcomes

  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 outcomes

  1. Clinical Global Impression-Improvement Scale

    Time frame: Week 8

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

    • = Very much improved
    • = Much improved
    • = Minimally improved
    • = No change
    • = Minimally worse
    • = Much worse
    • = Very much worse

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Depression Diagnosis and Treatment in Parkinson Disease

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2006
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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