- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02286440
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (AMOD)
11. juni 2020 opdateret af: Paul E. Croarkin, Mayo Clinic
A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents.
This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform.
This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection.
These patients will have GeneSight® testing and will be randomized to one of two groups.
In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection.
In Group 2 (n=138), testing results will not be available to the patient's research treating clinician.
However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8).
The patients and the clinical raters will be blinded to group assignment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
179
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
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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
13 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 13-18, male or female, any race/ethnicity
- Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
- Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
- Ability to provide informed consent
Exclusion Criteria:
- Inability to speak English
- Inability or lack of willingness to provide informed consent and assent.
- Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
- Psychotropic medication change (including dosage) between screening & randomization visits.
- Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
- Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
- Significant unstable medical condition.
- Anticipated inability to attend scheduled study visits.
- Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
- Cytochrome (CYP) & serotonin transporter genomic testing within 5 years.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Behandling som sædvanlig gruppe
Behandling som sædvanlig gruppe vil have behandlingsanbefalinger baseret på klinisk vurdering
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Eksperimentel: GeneSight guided treatment
GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Baseline to endpoint change in depression
Tidsramme: 8 weeks
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The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Improvement of depressive symptoms
Tidsramme: 8 weeks
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Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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Clinical Global Impression (CGI) scale
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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Global Assessment Scale (CGAS)
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form
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8 weeks
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Improvement of depressive symptoms
Tidsramme: 8 weeks
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Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention
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8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paul Croarkin, D.O., Mayo Clinic
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.
Hjælpsomme links
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
1. februar 2015
Primær færdiggørelse (Faktiske)
6. februar 2019
Studieafslutning (Faktiske)
6. februar 2019
Datoer for studieregistrering
Først indsendt
5. november 2014
Først indsendt, der opfyldte QC-kriterier
5. november 2014
Først opslået (Skøn)
7. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14-005547
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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 .
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