Status:
UNKNOWN
Psychosocial Treatment of Depression in Parkinson's Disease
Lead Sponsor:
Amy Farabaugh, PhD
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Major Depressive Disorder
Parkinson's Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).
Detailed Description
CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here ...
Eligibility Criteria
Inclusion
- In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
- Written informed consent.
- Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
- Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
- Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
- Men or women 40-80 years of age
- HAMD-17 scores \> 14 at screen visit
- Score of 25 or greater on the Mini-Mental Status Examination
- Willing to come to MGH for screening and study participation
Exclusion
- Patients meeting any of the following criteria are to be excluded from the study:
- Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
- Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores \> 28
- The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
- Subjects who meet DSM-IV criteria for dementia
- Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
- Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00853346
Start Date
April 1 2007
End Date
April 1 2013
Last Update
November 16 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114