Langsiktig oppfølging KET-PD
Langtidsoppfølging for forsøkspersoner som er registrert i ketamin for behandling av depresjon ved Parkinsons sykdom (KET-PD)-studien
The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06510
- Yale New Haven Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).
Beskrivelse
Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Experimental: Ketamine Infusion
Participants who received 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394) |
Participants will receive 10 weeks of CBT Participants will receive standard of care treatment |
|
Placebo Comparator: Saline Infusion
Participants who received 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394) |
Participants will receive 10 weeks of CBT Participants will receive standard of care treatment |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Long-Term Change in Depression Severity
Tidsramme: 3 Months and 6 Months
|
Change in MADRS score following course of ketamine vs. placebo treatment at 3 and 6 month timepoints; and change in MADRS across treatment (ketamine/placebo) and follow-up (CBT/TAU) arms at 3 and 6 month timepoints. The scale used to measure depression severity is called The Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The overall score ranges from 0 to 60, higher MADRS score indicates more severe depression. |
3 Months and 6 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Apathy
Tidsramme: 3 Months and 6 Months
|
Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale |
3 Months and 6 Months
|
|
Change in Anxiety
Tidsramme: 3 Months and 6 Months
|
Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale |
3 Months and 6 Months
|
|
Change in Parkinson's Symptom Severity
Tidsramme: 3 Months and 6 Months
|
Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale |
3 Months and 6 Months
|
|
Change in Dyskinesia
Tidsramme: 3 Months and 6 Months
|
Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale |
3 Months and 6 Months
|
|
Change in Pain
Tidsramme: 3 Months and 6 Months
|
Changes in pain determined by the King's PD Pain Scale |
3 Months and 6 Months
|
|
Change in Fatigue
Tidsramme: 3 Months and 6 Months
|
Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS) |
3 Months and 6 Months
|
|
Change in Anhedonia
Tidsramme: 3 Months and 6 Months
|
Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS) |
3 Months and 6 Months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sophie E. Holmes, PhD, Yale University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Synukleinopatier
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Atferdssymptomer
- Nevrodegenerative sykdommer
- Bevegelsesforstyrrelser
- Parkinsonlidelser
- Basal ganglia sykdommer
- Oppførsel
- Depresjon
- Parkinsons sykdom
- Atferdsterapi
- Psykoterapi
- Atferdsdisipliner og aktiviteter
- Kognitiv atferdsterapi
- Terapeutikk
Andre studie-ID-numre
- 2000036071
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