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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: January 18, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in score on the IDS scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Score on the CGI-I scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]

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: 1
Participants will receive atomoxetine treatment
 Drug: Atomoxetine
40 to 80 mg qd for 8 weeks
Placebo Comparator: 2
Participants will receive placebo treatment
 Drug: Placebo
40 to 80 mg qd 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304161

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Daniel Weintraub, MD University of Pennsylvania
  More 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, DATR AK-TNGP1
Study First Received: March 15, 2006
Last Updated: January 18, 2012
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
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Antidepressive Agents
Atomoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013