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Treatment of Depression in Parkinson's Disease Trial

NCT ID: NCT00062738

Last Updated: 2015-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nortriptyline

drug

Group Type EXPERIMENTAL

Nortriptyline

Intervention Type DRUG

nortriptyline 25 - 75 mg q hs

paroxetine

drug

Group Type EXPERIMENTAL

paroxetine

Intervention Type DRUG

Paroxetine CR 12.5 - 25 mg q hs

placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

matching placebo

Interventions

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paroxetine

Paroxetine CR 12.5 - 25 mg q hs

Intervention Type DRUG

Nortriptyline

nortriptyline 25 - 75 mg q hs

Intervention Type DRUG

placebo

matching placebo

Intervention Type OTHER

Other Intervention Names

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Paxil CR Pamelor

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Psychosis
* Heart block
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Menza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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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 Dec 17.

Reference Type RESULT
PMID: 19092112 (View on PubMed)

Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Friedman J. Depression in Parkinson's disease: symptom improvement and residual symptoms after acute pharmacologic management. Am J Geriatr Psychiatry. 2011 Mar;19(3):222-9. doi: 10.1097/JGP.0b013e3181e448f7.

Reference Type DERIVED
PMID: 20808132 (View on PubMed)

Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Troster A. The impact of antidepressant treatment on cognitive functioning in depressed patients with Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2010 Spring;22(2):188-95. doi: 10.1176/jnp.2010.22.2.188.

Reference Type DERIVED
PMID: 20463113 (View on PubMed)

Other Identifiers

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4381

Identifier Type: -

Identifier Source: org_study_id