- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00304161
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Depression Diagnosis and Treatment in Parkinson Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Philadelphia Veterans Affairs Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease
- IDS score greater than 21
- Mini-Mental State Examination (MMSE) score greater than 15
Exclusion Criteria:
- Recent deep brain stimulation
- Currently participating in an antidepressant trial at a less than adequate dose and duration
- Severe depression or depression with suicide ideation
- History of liver toxicity
- Unstable medical disease or comorbid psychiatric disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Atomoxetine
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
40 to 80 mg orally once daily for 8 weeks
Andre navn:
|
Placebo komparator: Placebo
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
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40 to 80 mg orally once daily for 8 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale
Tidsramme: Week 8
|
The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population.
An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression.
The IDS-C was administered at every study visit.
The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.
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Week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinical Global Impression-Improvement Scale
Tidsramme: Week 8
|
The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
A participant scoring a 1 or 2 is considered a responder on the CGI scale. |
Week 8
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Atferdssymptomer
- Psykiske lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Stemningsforstyrrelser
- Parkinsonlidelser
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Synukleinopatier
- Nevrodegenerative sykdommer
- Depresjon
- Depressiv lidelse
- Parkinsons sykdom
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Adrenerge opptakshemmere
- Atomoksetinhydroklorid
Andre studie-ID-numre
- K23MH067894 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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