Psychosocial Treatment of Depression in Parkinson's Disease

Major Depressive Disorder Clinical Trial

Official title:

Psychosocial Treatment of Depression in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00853346
• Other study ID #: MH076037-01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 27, 2009
• Last updated: November 15, 2012
• Start date: April 2007
• Est. completion date: April 2013

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
• Cognitive Behavioral Therapy
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Amy Farabaugh, PhD	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).		screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24	No

External Links

•   Depression Clinical and Research Program