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 |
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| 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. |
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| 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. |
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| Gesamtstatus | Completed | ||||||
| Anfangsdatum | June 2003 | ||||||
| Fertigstellungstermin | January 2009 | ||||||
| Primäres Abschlussdatum | January 2009 | ||||||
| Phase | Phase 2 | ||||||
| Studientyp | Interventional | ||||||
| Primärer Ausgang |
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| Sekundäres Ergebnis |
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| 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 |
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| 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 |
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| Insgesamt offiziell |
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| Ort |
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| Standort Länder |
United States |
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| Überprüfungsdatum |
October 2015 |
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| Verantwortliche Partei |
Art: Sponsor |
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| 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 |
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| Studiendesign Info |
Zuweisung: Randomized Interventionsmodell: Parallel Assignment Hauptzweck: Treatment Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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