Status:
COMPLETED
Coping With Depression in Parkinson's Disease
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Depression
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's dis...
Detailed Description
Depression is the most common emotional problem found in persons with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and burden to caregiver...
Eligibility Criteria
Inclusion
- Persons with PD
- Confirmed diagnosis of PD with no significant motor fluctuations or dementia.
- Major Depression, Dysthymia, or Depression NOS (Clinically significant depression not otherwise specified).
- 35-85 years old.
- Willingness to ask a family member or friend, with whom the patient has regular contact, to be involved in treatment.
- Patients will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least 6 weeks prior to screening provided that they do not have plans to change these medications while in the study.
- Patients will be allowed to remain on sedative-hypnotics or anxiolytics that have been stabilized for at least 4 weeks prior to screening. Patients who are taking these medications at screening and qualify for participation will be asked to remain on a stable course of these medications throughout the trial.
- Taking a stable dose of dopaminergic replacement therapy for at least one month
- Persons with PD
Exclusion
- DSM-IV criteria for a psychotic disorder, bipolar disorder, organic brain syndrome, or psychoactive substance dependence or abuse (Nicotine or caffeine dependence is allowed). Other psychiatric co-morbidity is not exclusionary as long as the depressive disorder is primary.
- Active suicidal ideation.
- An unstable major medical condition that would interfere with the study.
- Plans to engage in additional psychotherapy during the study (PD support group is ok).
- A diagnosis of dementia, defined as above.
- Significant motor fluctuations, defined as above; mild end of dose wearing off is allowed.
- Patients unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.
- Use of mood-stabilizers or antipsychotic medication.
- Caregiver Inclusion Criteria:
- Ages 25 to 85
- Daily contact with a friend, family member, or spouse with depression and PD \*MMSE \> 26 \[Mini Mental Status Exam score of greater than 26 (i.e., no signs of significant memory impairment)\].
- Caregiver
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00464464
Start Date
April 1 2007
End Date
March 1 2013
Last Update
November 5 2014
Active Locations (1)
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1
Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317
Piscataway, New Jersey, United States, 08854