Study of Antidepressants in Parkinson's Disease

NCT00086190 | Completed Phase 3 Results DMC

• 1 other identifier: R01NS046487
• Study Type: interventional
• Target: 115
• Locations: 3 countries
• Sites: 18

Brief Summary

The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Conditions

Parkinson Disease; Depression

Keywords

Parkinson disease; depression; Parkinson's disease; paroxetine; venlafaxine; antidepressant

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HAM-D) Scores

  Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Secondary Outcomes (16)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

• Change in Beck Depression Inventory II (BDI-II)

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

• Change in Geriatric Depression Rating Scale (GDS)

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

• Change in Brief Psychiatric Rating Scale (BPRS)

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

• Change in Unified Parkinson's Disease Rating Scale (UPDRS)

  from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Study Arms (3)

paroxetine

ACTIVE COMPARATOR

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Drug: paroxetine

venlafaxine extended release

ACTIVE COMPARATOR

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Drug: venlafaxine

placebo

PLACEBO COMPARATOR

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Other: placebo

Interventions

paroxetine DRUG

Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.

Also known as: Paxil

paroxetine

venlafaxine DRUG

Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.

Also known as: Effexor XR

venlafaxine extended release

placebo OTHER

an inactive substance

placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible you must be:
• years old or older
• diagnosed with Parkinson's disease
• experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (18)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Maryland

Baltimore, Maryland, 21250, United States

Location

Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Medical University of Ohio

Toledo, Ohio, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Tennessee-Memphis

Memphis, Tennessee, 38163, United States

Location

Baylor College of Medicine, 6550 Fannin, Suite 1801

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22901, United States

Location

London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road

London, Ontario, N6A 5A5, Canada

Location

Hotel-Dieu Hospital-CHUM

Montreal, Quebec, H2W 1T8, Canada

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

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MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Paroxetine; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Irene H. Richard, MD
• Organization: University of Rochester Medical Center

irene_richard@urmc.rochester.edu

585-341-7500

Study Officials

• Irene Richard, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• William McDonald, MD

  Co-Principal Investigator--Emory University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Irene Richard, MD

Study Record Dates

• First Submitted: June 28, 2004
• First Posted: June 29, 2004
• Study Start: June 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 4, 2013
• Results First Posted: January 4, 2013

Record last verified: 2013-01

Locations

CA (2); US (15); PR (1)