NCT00062738

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2003

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 5, 2013

Completed
Last Updated

November 24, 2015

Status Verified

October 1, 2015

Enrollment Period

5.6 years

First QC Date

June 12, 2003

Results QC Date

December 5, 2012

Last Update Submit

October 27, 2015

Conditions

Parkinson DiseaseDepression

Keywords

Parkinson's diseaseParkinson diseasedepressionantidepressantsnortriptylineparoxetine

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale

    total score on HDRS (0-54 higher score is worse)

    8 weeks

Secondary Outcomes (1)

  • Percent Responders

    8 weeks

Study Arms (3)

nortriptyline

EXPERIMENTAL

drug

Drug: Nortriptyline

paroxetine

EXPERIMENTAL

drug

Drug: paroxetine

placebo

PLACEBO COMPARATOR

placebo

Other: placebo

Interventions

paroxetineDRUG

Paroxetine CR 12.5 - 25 mg q hs

Also known as: Paxil CR
paroxetine
NortriptylineDRUG

nortriptyline 25 - 75 mg q hs

Also known as: Pamelor
nortriptyline
placeboOTHER

matching placebo

placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychosis
  • Heart block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

  • 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.

    PMID: 19092112RESULT

  • 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.

    PMID: 20808132DERIVED

  • 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.

    PMID: 20463113DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDepression

Interventions

ParoxetineNortriptyline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

This was only an eight week trial with relatively few participants.

Results Point of Contact

Title
Matthew Menza, MD
Organization
UMDNJ - RWJMS
menza@umdnj.edu
732-235-4440

Study Officials

  • Matthew Menza, M.D.

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2003

First Posted

June 13, 2003

Study Start

June 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 24, 2015

Results First Posted

March 5, 2013

Record last verified: 2015-10

Locations

US(1)