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

Parkinson Disease Clinical Trial

Official title:

Depression Diagnosis and Treatment in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304161
• Other study ID #: K23MH067894
• Secondary ID: K23MH067894
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2006
• Last updated: March 10, 2015
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease

Intervention

Drug:
• Atomoxetine
40 to 80 mg orally once daily for 8 weeks
• Placebo
40 to 80 mg orally once daily for 8 weeks

Locations

Country	Name	City	State
United States	Philadelphia Veterans Affairs Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale	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.	Week 8	No
Secondary	Clinical Global Impression-Improvement Scale	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.	Week 8	No

External Links

•   Manuscript