Billeddannelse af GABAerge/glutamaterge lægemidler hos bipolære alkoholikere alkoholikere
8. december 2023 opdateret af: James J. Prisciandaro, Medical University of South Carolina
Billeddannelsesramme for testning af GABAerge/glutamaterge lægemidler hos bipolære alkoholikere
Den foreslåede 3-ugers, dobbeltblinde, crossover, proof of concept-undersøgelse har til formål at manipulere neurokemiske dysfunktioner, der er karakteristiske for personer med samtidig forekommende BD og AUD (dvs. unormalt lavt præfrontal GABA og glutamat), ved hjælp af medicin, der har vist sig at normalisere cortical GABA (dvs. gabapentin) og glutamat (dvs. NAC) niveauer i tidligere forskning og for at evaluere medicinrelaterede ændringer i responshæmning og alkohol-cue-reaktivitet fMRI-opgaver samt drikke og humør hos personer med AUD+BD.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Bipolar lidelse (BD) er den psykiatriske akse I-tilstand, der er stærkest forbundet med stofbrugsforstyrrelse (SUD); diagnostisk co-forekomst er særligt høj mellem BD og alkoholmisbrug (AUD).
Personer med samtidig forekommende SUD og BD (SUD+BD) har væsentligt dårligere kliniske resultater end dem med enten BD eller SUD alene.
Ikke desto mindre ved man ikke meget om optimal behandling for personer med SUD+BD; respons på lithium ser ud til at være dårlig, og kun et dobbeltblindt, randomiseret, placebokontrolleret forsøg med valproat har vist forbedrede drikkeresultater i denne population.
Traditionelt har behandlingsforsøg for SUD+BD undersøgt medicin, der er blevet godkendt af FDA til at behandle enten BD eller SUD i håb om, at sådanne lægemidler ville vise sig at være effektive hos personer med SUD+BD.
En anden tilgang til at udvælge og ideelt set udvikle medicin til SUD+BD-behandlingsforsøg ville være at målrette mod neurokemiske dysfunktioner, der er karakteristiske for personer med både BD og SUD.
Nyere forskning fra den nuværende efterforsker har vist unikke forstyrrelser i præfrontal gamma-aminosmørsyre (GABA) og glutamatkoncentrationer i denne population ved hjælp af protonmagnetisk resonansspektroskopi (1H-MRS), hvor individer med samtidig forekommende alkoholafhængighed (AD) og BD har signifikant lavere niveauer af GABA og glutamat i forhold til individer med BD alene, AD alene eller sunde kontroller.
Lavere niveauer af præfrontal GABA og glutamat var igen forbundet med forhøjet impulsivitet og alkoholtrang.
Den foreslåede 3-ugers, dobbeltblinde, crossover, proof of concept-undersøgelse vil evaluere: a) om medicin, der har vist sig at normalisere cortical GABA (dvs. gabapentin) og glutamat (dvs. N-Acetylcystein [NAC]) koncentrationer i personer med henholdsvis epilepsi og kokainafhængighed kan på samme måde handle for at normalisere præfrontale GABA- og glutamatniveauer hos personer med AUD+BD, og b) om normalisering af præfrontale GABA- og glutamatniveauer vil være forbundet med forbedringer i funktionel hjerneaktivitet til opgaver, der vurderer kerne neuroadfærdsmæssige underskud af AUD og BD (dvs. responshæmning, alkohol-cue-reaktivitet), samt drikke- og humørsymptomer.
Positive resultater kan understøtte undersøgelse af gabapentin og/eller NAC som supplerende behandlinger for AUD+BD i storstilede, randomiserede kliniske forsøg.
Vigtigst er det, at den foreslåede undersøgelse kan give succesfuld demonstration af en neuroadfærdsmæssig, multimodal neuroimaging platform til evaluering af det potentielle løfte om GABAerge og glutamaterge lægemidler til AUD og/eller BD, såvel som andre tilstande præget af GABAergisk/glutamaterg dysfunktion.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
54
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inkludering:
- Opfylder DSM-V diagnostiske kriterier for bipolar lidelse
- Brug af mindst én stemningsstabiliserende medicin
- Opfylder diagnostiske kriterier Alkoholforbrugsforstyrrelse, med aktivt drikkeri inden for den seneste måned.
Undtagelse:
- Alvorlig medicinsk eller ikke-inklusiv psykiatrisk sygdom
- Samtidig brug af benzodiazepinmedicin eller andre farlige lægemidler, hvis de tages sammen med gabapentin/N-acetylcystein
- Anamnese med klinisk signifikant hjerneskade
- Tilstedeværelse af ikke-MRI sikkert materiale eller klinisk signifikant klaustrofobi.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Gabapentin, derefter N-Acetylcystein, derefter Placebo Oral Capsule
Tre, 1-uges betingelser. Uge 1 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (dage 1-5), MR (dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg Uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg Uge 3 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og udvaskning af medicin (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
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Eksperimentel: N-Acetylcystein, derefter Placebo Oral Capsule, derefter Gabapentin
3, 1 uges betingelser. Uge 1 tilstand vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg Tilstanden i uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og udvaskning af medicin (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo Uge 3 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (dage 1-5), MR (dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
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Placebo komparator: Placebo Oral Tablet, derefter Gabapentin, derefter N-Acetylcystein
Tre, 1-uges betingelser. Uge 1 tilstand vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og medicinudvaskning (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo Uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (dage 1-5), MR (dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg Uge 3 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
|
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Eksperimentel: Placebo Oral Capsule, derefter N-Acetylcystein, derefter Gabapentin
Tre, 1-uges betingelser. Uge 1 tilstand vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og medicinudvaskning (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo Uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg Uge 3 tilstand vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (Dag 1-5), MR (Dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
|
|
Eksperimentel: Gabapentin, derefter Placebo Oral Capsule, derefter N-Acetylcystein
Tre, 1-uges betingelser. Uge 1 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (dage 1-5), MR (dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg Tilstanden i uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og udvaskning af medicin (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo Uge 3 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
|
|
Eksperimentel: N-acetylcystein, derefter Gabapentin, derefter placebo oral kapsel
Tre, 1-uges betingelser. Uge 1 tilstand vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 2.400 mg N-acetylcystein) (dage 1-5), MR (dag 5) og udvaskning af medicin (dage 5-7). N-acetylcystein: 5 dages forsøg med N-acetylcystein med titrering til 2.400 mg Uge 2 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dvs. 1.200 mg gabapentin) (dage 1-5), MR (dag 5) og udvaskning af medicin (Dag 5-7). Gabapentin: 5 dages forsøg med gabapentin med titrering til 1.200 mg Uge 3 vil bestå af et personligt studiebesøg til vurdering og udlevering af medicin (dag 1), titrering til maksimal dosis (dag 1-5), MR (dag 5) og udvaskning af medicin (dag 5-7). Placebo oral tablet: 5 dages forsøg med matchet placebo |
5 dages forsøg med gabapentin med titrering til 1.200 mg
5 dages forsøg med N-acetylcystein med titrering til 2.400 mg
5 dages forsøg med matchet placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Præfrontale GABA+ koncentrationer
Tidsramme: Dag 5 i hver forsøgstilstand
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Koncentrationer af GABA+, refereret til ikke-undertrykt vand og korrigeret for in-voxel CSF-andel, i dorsal anterior cingulate cortex målt via protonmagnetisk resonansspektroskopi (dvs. MEGA-PRESS).
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Dag 5 i hver forsøgstilstand
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Præfrontale Glx-koncentrationer
Tidsramme: Dag 5 i hver forsøgstilstand
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Koncentrationer af Glx (dvs. glutamat + glutamin), refereret til ikke-undertrykt vand og korrigeret for in-voxel CSF-andel, i dorsale anterior cingulate cortex målt via protonmagnetisk resonansspektroskopi.
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Dag 5 i hver forsøgstilstand
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James J Prisciandarao, Ph. D, Medical University of South Carolina
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. august 2017
Primær færdiggørelse (Faktiske)
21. november 2022
Studieafslutning (Faktiske)
21. november 2022
Datoer for studieregistrering
Først indsendt
14. juli 2017
Først indsendt, der opfyldte QC-kriterier
14. juli 2017
Først opslået (Faktiske)
18. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. december 2023
Sidst verificeret
1. december 2023
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Alkohol-relaterede lidelser
- Stof-relaterede lidelser
- Stemningsforstyrrelser
- Bipolære og relaterede lidelser
- Alkoholisme
- Maniodepressiv
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Antivirale midler
- Analgetika
- Sensoriske systemagenter
- Excitatoriske aminosyreantagonister
- Excitatoriske aminosyremidler
- Beskyttelsesagenter
- Beroligende midler
- Psykotropiske stoffer
- Anti-angst midler
- Antikonvulsiva
- Antimaniske midler
- Respiratoriske midler
- Antioxidanter
- Modgift
- Frie radikale scavengers
- Ekspektoranter
- Gabapentin
- Acetylcystein
- N-monoacetylcystin
Andre undersøgelses-id-numre
- 64964
- R01AA025365 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Maniodepressiv
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Vielight Inc.Ikke rekrutterer endnuBipolar lidelse (BD) | Bipolar | Bipolar lidelse DepressionCanada
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Xenon Pharmaceuticals Inc.RekrutteringManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseForenede Stater
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University of California, Los AngelesUniversity of Colorado, Denver; University of Pittsburgh; University of Cincinnati og andre samarbejdspartnereRekrutteringTeenagere | Bipolar lidelse (BD) | Bipolar lidelse I eller II | Bipolar lidelse NOS | Bipolar spektrum lidelseForenede Stater
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Joshua RosenblatAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SAfsluttetBipolar IForenede Stater, Frankrig, Rumænien, Polen, Canada, Ungarn, Japan, Korea, Republikken, Malaysia, Taiwan
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Joshua RosenblatAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada
Kliniske forsøg med Gabapentin
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Samuel Lunenfeld Research Institute, Mount Sinai...Afsluttet
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University of KarachiCenter for Bioequivalence Studies and Clinical Research; Merck Pvt. Ltd...AfsluttetSunde frivillige | BioækvivalensundersøgelsePakistan
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Viatris Specialty LLCAfsluttetMisbrugspotentialeForenede Stater
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Indiana UniversityAfsluttet
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Endo PharmaceuticalsAfsluttetKarpaltunnelsyndrom | Kompleks regionalt smertesyndrom | Perifer neuropati | Diabetisk neuropati | Postherpetisk neuralgi | HIV neuropati | Idiopatisk sensorisk neuropatiForenede Stater
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Kaohsiung Medical University Chung-Ho Memorial...National Taiwan University Hospital; Merck Sharp & Dohme LLC; National Cheng-Kung...UkendtIkke-traumatisk osteonekroseTaiwan
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Eunice Kennedy Shriver National Institute of Child...Afsluttet
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XenoPort, Inc.Afsluttet