Treatment of Depression in Parkinson's Disease Trial

Depression Clinical Trial

Official title:

Treatment of Depression in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062738
• Other study ID #: 4381
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2003
• Last updated: October 27, 2015
• Start date: June 2003
• Est. completion date: January 2009

Study information

• Verified date: October 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.

Description:

Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.

Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.

A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

inclusion criteria:

• Parkinson's disease without dementia.

• Depression.

• Males or females.

exclusion criteria:

• Psychosis

• Heart block

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease

Intervention

Drug:
• paroxetine
Paroxetine CR 12.5 - 25 mg q hs
• Nortriptyline
nortriptyline 25 - 75 mg q hs

Other:
• placebo
matching placebo

Locations

Country	Name	City	State
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale	total score on HDRS (0-54 higher score is worse)	8 weeks	No
Secondary	Percent Responders	Percent of patients who had a 50% decrease in total HDRS at 8 weeks	8 weeks	No