• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: Treating Depression in Parkinson's Disease:  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. A New Method
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT00464464
Study ID: 1K23NS052155-01A2

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  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. treatment. Several studies are currently examining the effectiveness  EffectivenessAbility of a drug or treatment to produce a result. 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,  TherapyAnother word for “treatment”. 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.

Study Phase

Not Specified
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Depression

Time Commitment

• Less than six months
• For persons with PD, ten weekly sessions. For caregivers, four separate educational sessions.

Eligibility

• Minimum Age: 25
• Maximum Age: 85
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

• FOR PERSONS WITH PD:
• Confirmed diagnosis of PD with no significant motor fluctuations or dementia.  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• 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  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. 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)].

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.

Enrollment

Expected Enrollment: 160 (US)
Date Enrollment Began: Apr 01 2007
Last Updated Date: May 01 2007
Trial Post Date: May 01 2007
Website: http://clinicaltrials.gov/ct/show/NCT00464464?order=1

Primary Contacts and Locations

New Jersey

• Roseanne D. Dobkin, PhD — Principal Investigator
  University of Medicine and Dentistry of New Jersey (UMDNJ)
  dobkinro@umdnj.edu
  Phone: (732) 235-4051
  Robert Wood Johnson Medical School
  675 Hoes Lane, Room D-317
  Piscataway, NJ 08854
  USA