Clinical trial NCT00853346: Psychosocial Treatment of Depression in Parkinson's Disease
Official title: Psychosocial Treatment of Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Parkinson's Disease
Keywords: Depression
Parkinson's Disease
Major Depression
Cognitive Behavioral Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2009-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).

Detailed description: CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.

Eligibility criteria: Inclusion Criteria:

In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:

* Written informed consent.
* Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
* Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
* Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
* Men or women 40-80 years of age
* HAMD-17 scores \> 14 at screen visit
* Score of 25 or greater on the Mini-Mental Status Examination
* Willing to come to MGH for screening and study participation

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded from the study:

* Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
* Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores \> 28
* The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
* Subjects who meet DSM-IV criteria for dementia
* Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
* Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed

Primary outcomes:
measure: Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
timeFrame: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Amy Farabaugh, PhD
role: PRINCIPAL_INVESTIGATOR
References: