Forudsigelse af SSRI-effektivitet hos veteraner med PTSD (SSRI)
30. april 2026 opdateret af: VA Office of Research and Development
En elektrofysiologisk prædiktor for SSRI-respons hos veteraner med PTSD
Dette er et forskningsstudie for at undersøge effektiviteten af en kort screeningsmetode, der kan forudsige, hvilke personer med posttraumatisk stresslidelse (PTSD) eller depression, der med størst sandsynlighed vil vise en positiv respons på selektive serotoningenoptagshæmmere (SSRI) medicin.
Deltagerne vil blive rekrutteret over cirka 5,25 år, indtil mindst 94 deltagere gennemfører det 17 uger lange studie.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Selektive serotoningenoptagelseshæmmere (SSRI'er) ordineres til cirka 60 % af veteraner med PTSD, der behandles af Veterans Health Administration (VHA). Imidlertid reagerer mange patienter ikke på SSRI'er. I øjeblikket er der ingen måde at afgøre, om en bestemt patient vil have gavn af en SSRI; behandling udføres primært gennem 'trial and error' over flere uger eller måneder. Det overordnede mål med denne undersøgelse er at undersøge nytten før behandling af en simpel elektrofysiologisk test til at forudsige sandsynligheden for en gunstig respons på en SSRI. Denne undersøgelse vil undersøge, om en kort før-behandling auditiv hændelsesrelateret potentialeprocedure [fremover omtalt som "Loudness Dependence of Auditory Evoked Potentials" (LDAEP)] tilbyder et middel til at forudsige behandlingsrespons på en SSRI for mænd og kvinder diagnosticeret med PTSD eller depression.
Denne undersøgelse har fire formål: 1) At bestemme styrken af forholdet mellem LDAEP og klinisk respons på SSRI-behandling. 2) At bestemme LDAEP-afskæringsværdier, der ville gøre det muligt for klinikere at lave individuelle SSRI-behandlingsanbefalinger. 3) At vurdere nytten af ændringer i LDAEP som et objektivt mål for SSRI-respons. 4) Udforskende: For at bestemme, om forholdet mellem LDAEP og klinisk respons på sertralin er forskellig mellem mænd og kvinder.
Midler til at beskytte forsøgspersoners identitet:
For at sikre fortrolighed vil spørgeskema- og interviewdata blive opbevaret i aflåste arkivskabe i aflåste kontorer. Hver deltager vil have sit eget deltagernummer, og disse numre vil være den eneste måde, hvorpå deltageroplysninger kan identificeres. Elektroniske data vil blive gemt på et sikkert privat, adgangskodebeskyttet drev, som kun kan tilgås af medlemmer af undersøgelsesteamet og kun mærket med deltagernummeret. En liste over navne og deltagernumre vil blive opbevaret på en privat, adgangskodebeskyttet computerkonto på et separat drev fra de afidentificerede data og kun tilgængelig for undersøgelsesholdet.
ADMINISTRATION AF LÆGEMIDLER I FORSKNING, IKKE FINANSIERET AF NIH Beskrivelse af identifikation af lægemiddel: SERTRALINE. Fordi målet med denne undersøgelse er at identificere præ-behandlingsprædiktorer for SSRI-respons, som i sidste ende kunne bruges i rutinemæssig klinisk pleje, designede efterforskerne undersøgelsen med økologisk validitet i tankerne. Specifikt valgte efterforskerne sertralin som undersøgelsesmedicin, fordi det er: a) det mest almindeligt ordinerede SSRI i USA, b) et af kun to FDA-godkendte lægemidler til behandling af PTSD og c) et af de to mest effektive SSRI'er til behandling af PTSD. svær depression, en almindelig komorbiditet med PTSD. Dosering vil følge kliniske retningslinjer, dvs. doser vil blive valgt baseret på klinisk respons og tolerabilitet.
Beskrivelse af administration af lægemiddel: Efterforskerne bruger en tilgang, som repræsenterer forbedret klinisk pleje, idet deltagerne diskuterer medicinniveauer, bivirkninger og symptomer med en psykiater hver anden uge. Studiemedicin og placebo vil blive opbevaret og distribueret af VA Boston Pharmacy service.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
26
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29401-5703
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
-
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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- har en historie med traumeeksponering som defineret af kriterium A for PTSD i DSM-5
- opfylder diagnostiske kriterier for PTSD, subthreshold PTSD eller MDD som defineret af DSM-5
- studere psykiaterens vurdering af, at SSRI'er er en acceptabel behandlingsmulighed for deltagerens bekymringer, og
- interesse i at starte et forsøg med et SSRI
Ekskluderingskriterier:
- nuværende eller tidligere historie med bipolar lidelse I, skizofrene eller andre psykotiske lidelser
- aktuelle organiske hjernelidelser, herunder alvorlig traumatisk hjerneskade, faktuelle lidelser eller maling
- graviditet
- store neurologiske problemer
- nuværende moderat eller svær stofmisbrugsforstyrrelse
- aktiv risiko for sig selv eller andre
- tegn på klinisk signifikant lever- eller nyresygdom eller enhver anden akut eller ustabil medicinsk tilstand, der kan forstyrre sikker gennemførelse af undersøgelsen
- intolerance eller overfølsomhed over for sertralin
- mislykket tidligere forsøg med sertralin (bekræftet af journalgennemgang)
- brug af lægemidler, der direkte påvirker serotoninsystemet (f.eks. SNRI'er, antipsykotika) inden for 3 måneder efter undersøgelsen
- brug af et SSRI inden for 3 måneder efter undersøgelsen. Brug af anden psykotrop medicin skal have været stabil i 3 måneder før tilmelding og forblive stabil under hele deltagelsen
- hørenedsættelse for 780 Hz toner
- nuværende indskrivning i traumefokuseret psykoterapi
for de deltagere, der i øjeblikket har en ikke-VA- eller VA-psykiater eller primær plejeudbyder, som er villig til at ordinere medicin, skal de være villige til at underskrive en frigivelse af information (ROI) for undersøgelsespersonale til at kommunikere med deres udbydere, og udbyderen mener, at at inkludere deltageren i undersøgelsen er potentielt passende.
Som diskuteret ovenfor vil efterforskerne informere deltageren om, at efterforskerne vil dele følgende oplysninger med deres aktuelle relevante plejeudbyder:
- oplysninger om undersøgelsens design, inklusions- og eksklusionskriterier, deltagerens psykiatriske og medicinske diagnoser samt sygdommens sværhedsgrad, som vurderet i screeningsevalueringen, og enhver historie med sikkerhedsproblemer såsom risiko for sig selv eller andre.
- Hvis deltageren ikke underskriver en frigivelse af information (ROI) for at kontakte udbyderen, vil deltageren ikke indgå i den aktive undersøgelse.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo kun arm
For personer, der er placebo-responderende i løbet af den 2-ugers placebo-indledende fase, vil de forblive på placebo i hele undersøgelsens varighed (dvs. de 12 uger, hvor placebo-non-respondenterne tager sertralin).
|
Dette er en ERP-opgave, hvor deltagerne hører en række toner fra 74dB til 104dB, og elektrofysiologisk aktivitet måles hele vejen igennem.
For hver deltager udledes gennemsnitlige P2-score for 74dB-toner, 84dB-toner, 94dB-toner og 104dB-toner.
Derefter defineres LDAEP som hældningen af disse gennemsnitlige P2-scores.
placebo-piller af samme størrelse, farve og smag som det aktive lægemiddel vil blive administreret
|
|
Aktiv komparator: Sertralin arm
Efter den 2-ugers placebo-indføringsfase vil placebo-non-respondanter modtage sertralin 25 mg dagligt i 2 uger.
Derefter vil sertralin øges fleksibelt med 25 til 50 mg pr. dag (med en hastighed, der ikke er højere end 50 mg pr. uge) for at opnå en samlet daglig dosis på 50 til 200 mg, baseret på klinisk respons og tolerabilitet, med en maksimal dosis på 200 mg/d.
Forsøgspersoner, der ikke er i stand til at tolerere højere doser, kan falde tilbage til den tidligere dosis og forblive på denne dosis i resten af undersøgelsen.
|
Dette er en ERP-opgave, hvor deltagerne hører en række toner fra 74dB til 104dB, og elektrofysiologisk aktivitet måles hele vejen igennem.
For hver deltager udledes gennemsnitlige P2-score for 74dB-toner, 84dB-toner, 94dB-toner og 104dB-toner.
Derefter defineres LDAEP som hældningen af disse gennemsnitlige P2-scores.
placebo-piller af samme størrelse, farve og smag som det aktive lægemiddel vil blive administreret
Sertralin er et FDA godkendt SSRI til behandling af PTSD.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score
Tidsramme: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD.
This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity.
Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme.
The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
|
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score
Tidsramme: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD.
This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity.
Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme.
The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
|
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score
Tidsramme: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD.
This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity.
Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme.
The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
|
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score
Tidsramme: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD.
This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity.
Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme.
The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
|
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score
Tidsramme: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
The CAPS-5 is the "gold standard" clinical interview for assessing PTSD.
This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity.
Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme.
The total range of the CAPS-5 is 0-80, higher scores indicating higher symptom severity.
|
CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The QIDS-SR was used to measure the severity of depressive symptoms.
The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.
The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The QIDS-SR was used to measure the severity of depressive symptoms.
The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.
The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The QIDS-SR was used to measure the severity of depressive symptoms.
The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.
The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The QIDS-SR was used to measure the severity of depressive symptoms.
The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.
The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The QIDS-SR was used to measure the severity of depressive symptoms.
The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.
The range for the total QIDS-SR severity score is 0-42, with higher scores indicating worse depression severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the FZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
|
PTSD Checklist for DSM-5 (PCL-5) as Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site)
Tidsramme: Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD, anchored to participants' worst traumatic event.
The PCL-5 was administered bi-weekly at each psychiatrist check-in visit.
Participants rated how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80).
Higher scores indicate greater PTSD severity.
|
Administered at weeks 0, 2, 4, 6, 8, 10, 12, and 14
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Suzanne Pineles, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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)
11. september 2019
Primær færdiggørelse (Faktiske)
30. marts 2025
Studieafslutning (Faktiske)
31. marts 2025
Datoer for studieregistrering
Først indsendt
27. november 2019
Først indsendt, der opfyldte QC-kriterier
27. november 2019
Først opslået (Faktiske)
3. december 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Traumer og stressor-relaterede lidelser
- Psykiske lidelser
- Adfærdsmæssige symptomer
- Stemningsforstyrrelser
- Stresslidelser, traumatiske
- Depressiv lidelse
- Opførsel
- Depression
- Depressiv lidelse, major
- Stresslidelser, posttraumatisk
- Organiske kemikalier
- Kulbrinter
- Kulbrinter, cyklisk
- Naphthalenes
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Aminer
- 1-naphthylamin
- Sertralin
Andre undersøgelses-id-numre
- MHBB-028-17F
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Et afidentificeret, anonymiseret datasæt vil blive oprettet og delt efter undersøgelsens afslutning.
IPD-delingstidsramme
Data vil være tilgængelige inden for et år efter indsendelse af den endelige rapport.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
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 Større depressiv lidelse
-
Rotman Research Institute at BaycrestRekrutteringMajor Depressive Disorder (MDD)Canada
-
ACADIA Pharmaceuticals Inc.RekrutteringDepressiv lidelse, behandlingsresistent | Major Depressive Disorder (MDD)Forenede Stater
-
University of PretoriaIkke rekrutterer endnuMajor Depressive Disorder (MDD)Saudi Arabien
-
Tel Aviv UniversityIkke rekrutterer endnuMajor Depressive Disorder (MDD)Israel
-
Yonggui YuanIkke rekrutterer endnuMajor Depressive Disorder (MDD)Kina
-
Daniel LindqvistLund University; KetabonRekrutteringMajor Depressive Disorder (MDD)Sverige
-
King's College LondonCardiff and Vale University Health Board; South London and Maudsley NHS... og andre samarbejdspartnereRekrutteringMajor Depressive Disorder (MDD)Det Forenede Kongerige
-
Supernus Pharmaceuticals, Inc.RekrutteringMajor Depressive Disorder (MDD)Forenede Stater
-
University of PennsylvaniaRekruttering
-
The Second Hospital of Anhui Medical UniversityIkke rekrutterer endnu