Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304161
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2006-03-15
Brief Title:
Effectiveness of Antidepressant Treatment for Depression in People With Parkinsons Disease
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Depression Diagnosis and Treatment in Parkinson Disease
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinsons disease
Detailed Description:
Depression is a serious medical condition that affects peoples thoughts feelings and ability to function in everyday life Depression can happen to anyone but it is more of a risk in people with Parkinsons disease a progressive brain disorder that is caused by a loss of dopamine-producing brain cells As many as half of people with Parkinsons 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 Parkinsons 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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH067894 | NIH | None | httpsreporternihgovquickSearchK23MH067894 |