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Study of Antidepressants in Parkinson's Disease (SAD-PD)

3 januari 2013 uppdaterad av: Irene Richard, University of Rochester
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.

The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.

This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.

Studietyp

Interventionell

Inskrivning (Faktisk)

115

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna, 94143
        • University of California San Francisco
    • Florida
      • Gainesville, Florida, Förenta staterna, 32610
        • University of Florida
      • Miami, Florida, Förenta staterna, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University School of Medicine
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21218
        • Johns Hopkins University
      • Baltimore, Maryland, Förenta staterna, 21250
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
    • Missouri
      • St. Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
    • New York
      • Rochester, New York, Förenta staterna, 14627
        • University of Rochester
    • Ohio
      • Toledo, Ohio, Förenta staterna
        • Medical University of Ohio
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health Sciences University
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38163
        • University of Tennessee-Memphis
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Baylor College of Medicine, 6550 Fannin, Suite 1801
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22901
        • University of Virginia
  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 5A5
        • London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
    • Quebec
      • Montreal, Quebec, Kanada, H2W 1T8
        • Hotel-Dieu Hospital-CHUM
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

To be eligible you must be:

  • 30 years old or older
  • diagnosed with Parkinson's disease
  • experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Läkemedel: paroxetine
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.
Andra namn:
  • Paxil
Aktiv komparator: venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Läkemedel: venlafaxine
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.
Andra namn:
  • Effexor XR
Placebo-jämförare: placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Övrig: placebo
ett inaktivt ämne

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Hamilton Depression Rating Scale (HAM-D) Scores
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Beck Depression Inventory II (BDI-II)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Geriatric Depression Rating Scale (GDS)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Brief Psychiatric Rating Scale (BPRS)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Snaith Clinical Anxiety Scale (CAS)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Pittsburgh Sleep Quality Index (PSQI)
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Component Summary
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Vitality
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Role-Emotional
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Health
Tidsram: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Rochester

Samarbetspartners

National Institute of Neurological Disorders and Stroke (NINDS)

Utredare

  • Huvudutredare: Irene Richard, MD, University of Rochester
  • Huvudutredare: William McDonald, MD, Co-Principal Investigator--Emory University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2005

Primärt slutförande (Faktisk)

1 november 2009

Avslutad studie (Faktisk)

1 november 2009

Studieregistreringsdatum

Först inskickad

28 juni 2004

Först inskickad som uppfyllde QC-kriterierna

28 juni 2004

Första postat (Uppskatta)

29 juni 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 januari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 januari 2013

Senast verifierad

1 januari 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • R01NS046487 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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