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Parkinson's Disease Clinical Trials For posting and discussion of clinical trials related to Parkinson's Disease, and for the Parkinson Pipeline Project. All are welcome. |
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05-31-2007, 06:07 PM | #1 | |||
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Coping With Depression in Parkinson’s Disease
Official Study Title: Treating Depression in Parkinson's Disease: A New Method Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Clinicaltrials.gov ID: NCT00464464 Study ID: 1K23NS052155-01A2 Last Updated Date: 01 May 2007 Summary 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 caregivers. Despite the adverse consequences of depression in PD, there are virtually no studies to guide clinical treatment. Several studies are currently examining the effectiveness of antidepressant medication for depression in PD. However, there have been no studies to examine the effectiveness of non-medication approaches, such as cognitive-behavioral therapy, despite the success of these techniques in other populations. Cognitive-behavioral therapy teaches people with PD to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to symptoms of depression. The purpose of this study is to determine if cognitive-behavioral therapy — with a caregiver-focused social support intervention — is effective in treating depression in persons with PD. This study will enroll 160 persons — 80 with PD and 80 caregivers. Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care. The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments (four months after the initial evaluation). The study treatment will consist of ten weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD. Caregivers will attend four separate educational sessions — lasting 30 minutes each — designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions. Duration of the study for participants is 15 weeks. This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial. Information gained from this study may be beneficial in treating depression in persons with PD. Enrollment Expected Enrollment: 160 Trial Phase Study Phase: Not Specified (About Phases) Symptoms # Depression Time Commitment Length of Time Commitment: Less than six months Frequency of office visits: For persons with PD, ten weekly sessions. For caregivers, four separate educational sessions. Eligibility Minimum Age: 25 Maximum Age: 85 Trial accepts healthy volunteers Inclusion Criteria FOR 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).[*]Ages 35 to 85.[*]Willingness to ask a family member or friend, with whom the participant has regular contact, to be involved in treatment.[*]Participants will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least six weeks prior to screening provided that they do not have plans to change these medications while in the study.[*]Taking a stable dose of dopaminergic replacement therapy for at least one month. FOR CAREGIVERS:[*]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)].[/LIST]Exclusion Criteria
Roseanne D. Dobkin, PhD Principal Investigator University of Medicine and Dentistry of New Jersey (UMDNJ) Phone : (732) 235-4051 dobkinro@umdnj.edu Robert Wood Johnson Medical School 675 Hoes Lane, Room D-317 Piscataway, NJ 08854 USA redline.jpg Full Details: PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1[LIST][*]Complete list of PD trials redline.jpg Parkinson Pipeline Project] www.pdpipeline.org Following theapies from pre-clinical development to approval in the Parkinson Pipeline Project Database (see homepage for link to database) redline.jpg
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