Treatment of Depression in Parkinson's Disease Trial

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease; Depression

Treatments: Other: placebo; Drug: paroxetine; Drug: Nortriptyline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00062738

4381

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinson's disease without dementia.
• Depression.
• Males or females.

Exclusion criteria

• Psychosis
• Heart block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

nortriptyline

Experimental group

Description:

drug

Treatment:

Drug: Nortriptyline

paroxetine

Experimental group

Description:

drug

Treatment:

Drug: paroxetine

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: placebo