Treatment of Depression in Parkinson's Disease Trial

Treatment of Depression in Patients With Parkinson's Disease

Sponsoren

Hauptsponsor: Rutgers, The State University of New Jersey

Mitarbeiter: GlaxoSmithKline

Quelle Rutgers, The State University of New Jersey
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum June 2003
Fertigstellungstermin January 2009
Primäres Abschlussdatum January 2009
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Hamilton Depression Scale 8 weeks
Sekundäres Ergebnis
Messen Zeitfenster
Percent Responders 8 weeks
Einschreibung 52
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: paroxetine

Beschreibung: Paroxetine CR 12.5 - 25 mg q hs

Armgruppenetikett: paroxetine

Anderer Name: Paxil CR

Interventionsart: Drug

Interventionsname: Nortriptyline

Beschreibung: nortriptyline 25 - 75 mg q hs

Armgruppenetikett: nortriptyline

Anderer Name: Pamelor

Interventionsart: Other

Interventionsname: placebo

Beschreibung: matching placebo

Armgruppenetikett: placebo

Teilnahmeberechtigung

Kriterien:

inclusion criteria:

- Parkinson's disease without dementia.

- Depression.

- Males or females.

exclusion criteria:

- Psychosis

- Heart block

Geschlecht: All

Mindestalter: 35 Years

Maximales Alter: 80 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Matthew Menza, M.D. Principal Investigator Rutgers, The State University of New Jersey
Ort
Einrichtung: Robert Wood Johnson Medical School
Standort Länder

United States

Überprüfungsdatum

October 2015

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: nortriptyline

Art: Experimental

Beschreibung: drug

Etikette: paroxetine

Art: Experimental

Beschreibung: drug

Etikette: placebo

Art: Placebo Comparator

Beschreibung: placebo

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov