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

• FOR PERSONS WITH PD:
• Active suicidal thoughts.
• 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.
• Persons unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.
• Use of mood-stabilizers or antipsychotic medication.
  
  FOR CAREGIVERS:
• Active suicidal thoughts.
• An unstable major medical or psychiatric condition.
• Evidence upon clinical interview of substance abuse/dependence.

Primary Contact
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

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Full Details:

PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161

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ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1[LIST][*]Complete list of PD trials

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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)

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