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

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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


Condition Intervention Phase
Depressive Disorder
Parkinson Disease
Drug: Atomoxetine
Drug: Placebo
Phase 4

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
Official Title: Depression Diagnosis and Treatment in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 55
Study Start Date: July 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304161

Locations
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
Investigators
Principal Investigator: Daniel Weintraub, MD University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Daniel Weintraub, Associate Professor of Psychiatry and Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00304161     History of Changes
Other Study ID Numbers: K23 MH067894, K23MH067894
Study First Received: March 15, 2006
Results First Received: June 12, 2012
Last Updated: March 10, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Depression
Parkinson's Disease
Atomoxetine

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

ClinicalTrials.gov processed this record on May 03, 2015