- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04021433
Ketamine for Treatment Resistant MDD
Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study
Studieoversigt
Detaljeret beskrivelse
Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.
In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Jerusalem, Israel
- Rekruttering
- Hadassah Hebrew University Medical Center
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Kontakt:
- Isserles Moshe, MD, MSc
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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:
- Diagnosed with unipolar/bipolar depression with MADRS Score>= 20
- Inadequate response to >= 3 adequate treatment trials [>=2 trials in the present episode]
- If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
- QTc WNL
Exclusion Criteria:
- Hypersensitivity to ketamine
- Other major psychiatric diagnosis
- High suicidality
- Unstable physical illness
- S/P CVA / brain SOL
- Pregnant or breast feeding women
- Illicit drug/alcohol abuse during last year
- History of ketamine abuse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MDD
Treatment resistant patients will be treated with multiple doses of IM/SC ketamine [dose range 0.3-1.5mg/kg]
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Repeated doses of IM/SC ketamine up to 3 times a week
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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MADRS
Tidsramme: 1 month into treatment through study completion
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The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline
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1 month into treatment through study completion
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
MADRS
Tidsramme: 3 months into treatment
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The change in MADRS score at 3 months compared to baseline.
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3 months into treatment
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QIDS-SR, Clinical Global Impressions - Improvement
Tidsramme: along 6 months
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The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.
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along 6 months
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Average time in remission
Tidsramme: along 6 months
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Average time in remission.
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along 6 months
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NeuroTrax computerized cognitive battery
Tidsramme: along 6 months
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Changes in cognitive function at 1 and 6 months [or at study end] as assessed by the NeuroTrax computerized cognitive battery compared to baseline. correlation between information processing speed and other cognitive domains at baseline and clinical outcomes. |
along 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
- Psykiske lidelser
- Stemningsforstyrrelser
- Depressiv lidelse
- Depressiv lidelse, major
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler, dissociativ
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Excitatoriske aminosyreantagonister
- Excitatoriske aminosyremidler
- Ketamin
Andre undersøgelses-id-numre
- 58717-HMO-CTIL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Depressiv lidelse, major
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Shalvata Mental Health CenterUkendt
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Yonsei UniversityAfsluttet
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Section for Affective Disorders; Northern Stockholm...Afsluttet
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Gangnam Severance HospitalAfsluttetMajor Depressive Disorder (MDD)Korea, Republikken
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AccexibleRekrutteringMajor Depressive Disorder (MDD)Spanien
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ikke rekrutterer endnuMajor Depressive Disorder (MDD)
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekrutteringMajor Depressive Disorder (MDD)Kina
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Seasons Biotechnology (Taizhou) Co., Ltd.AfsluttetMajor Depressive Disorder (MDD)Indien
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GlaxoSmithKlineAfsluttet
-
Seasons Biotechnology (Taizhou) Co., Ltd.AfsluttetMajor Depressive Disorder (MDD)Indien
Kliniske forsøg med Ketamine
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Grace Lim, MD, MSNational Institute of Mental Health (NIMH)RekrutteringSmerter, postoperativ | Depression, postpartumForenede Stater
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Ullevaal University HospitalUniversity of OsloAfsluttet
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Assiut UniversityAfsluttetKetamin forårsager uønskede virkninger i terapeutisk brugEgypten
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Assistance Publique - Hôpitaux de ParisAfsluttetArtroplastik, udskiftning, hofteFrankrig
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Antonios LikourezosAfsluttet
-
Children's Hospital of MichiganAfsluttetModerat, dyb sedation
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Guangzhou Women and Children's Medical CenterSuspenderetAutismespektrumforstyrrelseKina
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Assiut UniversityAfsluttetPostoperativ smerteEgypten
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Ajou University School of MedicineUkendt
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Erasmus Medical CenterTilmelding efter invitationKomplekse regionale smertesyndromer | CRPS (komplekse regionale smertesyndromer)Holland