| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease | ||||
| Official Title † | Depression Diagnosis and Treatment in Parkinson Disease | ||||
| Brief Summary | This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease. |
||||
| 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. |
||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Change in score on the IDS scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Score on the CGI-I scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Depressive Disorder Parkinson Disease |
||||
| Intervention † | Drug: Atomoxetine Drug: Placebo |
||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 80 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 30 Years to 79 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00304161 | ||||
| Organization ID | K23 MH67894 | ||||
| Secondary IDs †† | DATR AK-TNGP1 | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | March 15, 2006 | ||||
| Last Updated Date | February 29, 2008 | ||||
|
