N/A
N=80
Coping With Depression in Parkinson's Disease
Parkinson's Disease · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00464464 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Hamilton Depression Rating Scale: Baseline — 20.93; 19.38 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cognitive-behavioral therapy (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale: Baseline |
20.93; 19.38 | — |
| PRIMARY Hamilton Depression Rating Scale: Midpoint |
14.92; 19.71 | — |
| PRIMARY Hamilton Depression Rating Scale: Endpoint |
13.58; 19.33 | — |
| PRIMARY Hamilton Depression Rating Scale: Follow-Up Evaluation |
14.52; 19.31 | — |
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 disease.
Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.
Eligibility Criteria
Persons with PD Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- Active suicidal ideation
- An unstable major medical or psychiatric condition
- Evidence upon clinical interview of substance abuse/dependence
Data sourced from ClinicalTrials.gov (NCT00464464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.