- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03069911
Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Depression is a common, but treatable, comorbid condition often seen in persons with Idiopathic Parkinson Disease (iPD). Depression in Parkinson Disease may be hard to treat as patients with iPD may be sensitive to side effect of medication. As a result, other treatments which have better side effects profiles than antidepressants may be equivalent (or better) options.
OnabotulinumtoxinA is a purified formulation of botulinum toxin serotype A which is widely utilized for neurological (and cosmetic) purposes in medicine. OnabotulinumtoxinA has preliminary studies showing it may be beneficial for the treatment of Major Depressive Disorder when given in isolated injections to facial muscles (corrugator and procerus). When given in low doses, onabotulinumtoxinA is thought to have minimal side effects.
The investigators propose that a single treatment onabotulinumtoxinA may improve symptoms of depression in persons with Parkinson Disease over three months compared to placebo. The investigators plan to use both subjective and objective evaluations of depression symptoms and regular physical exams to ensure physical (motor) symptoms of Parkinson Disease do not worsen.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written informed consent is obtained in the English language;
- They are a 18 to 95 years old;
- They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
- They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
- They are judged by the investigator to have the capacity to understand the nature of the study;
- They are willing to comply with all the requirements of the study;
- They are considered by the investigator to be likely to adhere to the protocol.
Exclusion Criteria:
- They have been treated with onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
- They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
- They have a history of substance abuse or dependence in the 2 months prior to screening;
- They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
- They are considered to be at significant risk of committing homicide;
- They have an unstable medical condition;
- Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
- There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
- They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
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OnabotulinumtoxinA (29 units for women; 40 units for men) diluted with 0.9% sodium chloride (saline) solution to 40 units per milliliter (mL) (0.725 mL for women, 1 mL for men)
Andre navne:
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Placebo komparator: Control
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
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0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hamilton Rating Scale for Depression (HDRS)
Tidsramme: Baseline and two visits over three months (weeks 6 and 12)
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Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)
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Baseline and two visits over three months (weeks 6 and 12)
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Clinical Global Impression - Improvement (CGI-I)
Tidsramme: Baseline and two visits over three months (weeks 6 and 12)
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Improvement on a measure of global change from screening to study discontinuation
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Baseline and two visits over three months (weeks 6 and 12)
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Clinical Global Impression - Severity (CGI-S)
Tidsramme: Baseline and two visits over three months (weeks 6 and 12)
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Improvement on measure of global illness severity from screening to study discontinuation
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Baseline and two visits over three months (weeks 6 and 12)
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Beck Depression Inventory II
Tidsramme: Baseline and two visits over three months (weeks 6 and 12)
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Improvement on a participant-rated subjective scale for depression as assessed over two visits
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Baseline and two visits over three months (weeks 6 and 12)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Clinical Severity Score for Glabellar Frown Lines
Tidsramme: Baseline and two visits over three months (weeks 6 and 12)
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Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
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Baseline and two visits over three months (weeks 6 and 12)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Stemningsforstyrrelser
- Parkinsonlidelser
- Basal Ganglia Sygdomme
- Bevægelsesforstyrrelser
- Synukleinopatier
- Neurodegenerative sygdomme
- Depression
- Depressiv lidelse
- Parkinsons sygdom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoxinA
Andre undersøgelses-id-numre
- IRB00082708
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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ProgenaBiomeRekrutteringDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RekrutteringDepression Moderat | Depression Alvorlig | Depression MildBelgien
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University of California, San FranciscoRekrutteringDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
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Baylor College of MedicineUniversity of TexasRekrutteringDepression | Depression Moderat | Depression Alvorlig | Selvmord og selvskade | Depression i ungdomsårene | Depression MildForenede Stater
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Charite University, Berlin, GermanyAfsluttetBehandlingsresistent depression | Depression, Unipolar | Depression KroniskTyskland
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
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University of California, San FranciscoIkke rekrutterer endnuDepression Moderat | Depression MildForenede Stater
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University of BernAfsluttetDepression Moderat | Depression MildSchweiz
Kliniske forsøg med OnabotulinumtoxinA
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AllerganAfsluttetGlabellar linjer | Kragefødder linjer | AnsigtsrytmerTyskland, Canada, Forenede Stater, Frankrig
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AllerganAfsluttetGlabellar linjer | Kragefødder linjer | AnsigtsrytmerTyskland, Canada, Forenede Stater, Frankrig
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Buddhist Tzu Chi General HospitalAfsluttet
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Henry Ford Health SystemAktiv, ikke rekrutterendeGlabellar pandelinjerForenede Stater
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Dartmouth-Hitchcock Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at... og andre samarbejdspartnereRekrutteringOveraktiv blære | Urininkontinens i alderdommen | Urininkontinens hasterForenede Stater
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Universita di VeronaMarialuisa GandolfiUkendt
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Seoul National University HospitalIpsen; Medical Research Collaborating Center, Seoul, KoreaAfsluttetCervikal dystoniKorea, Republikken
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The First Affiliated Hospital of University of...Ikke rekrutterer endnu
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Karolinska InstitutetAfsluttetCovid-19 | Blødende | Tromboemboliske hændelserSverige
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University of MichiganTrukket tilbageHæmodialyse | FarmakokinetikForenede Stater