Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Ændringer i hjernenetværk, der ledsager og forudsiger reaktioner på farmakoterapi ved OCD

21. september 2026 opdateret af: Yale University

The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The proposed study intends to recruit 2 groups:

  1. Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and
  2. a randomized, double-blind group of unmedicated OCD participants who will be assigned to begin either immediate or placebo-delayed treatment, and who will be imaged with fMRIs at baseline and over the course of treatment with a selective serotonin reuptake inhibitor (SSRI), fluoxetine.

Hypothesis-driven analyses and exploratory analyses will be performed in parallel.

This study will address the following Specific Aims:

  1. Identification of neural dysconnectivity associated with OCD symptomatology.
  2. Characterizing neural markers of clinical response to SSRI pharmacotherapy.
  3. Mapping neural predictors of clinical response to pharmacotherapy.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519
        • Rekruttering
        • Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST
        • Kontakt:
        • Kontakt:

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Inclusion criteria for all groups will include: (i) Adults, Men and women will be included, in a 1:1 ratio; and efforts will be made to recruit racial and ethnic subgroups. Groups will be further matched on age, handedness; and later, in analysis, on educational status and smoking history.

(ii) signed informed consent, approved by the Yale Human Investigations Committee; and (iii) ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans.

  • Additional inclusion criteria:

  • OCD Participants:

    (i) a DSM diagnosis of OCD, established as detailed above; (ii) a baseline Y-BOCS of ≥16; (iii) no current psychoactive medication, with the exception of the occasional use of a PRN medication for sleep; (iv) treatment seeking, and clinically appropriate for fluoxetine pharmacotherapy; (v) for women of childbearing potential, not pregnant or intending to become pregnant, and willing to use reliable birth control over the course of the study, either prescribed contraceptive (oral contraceptive, injectable, or implant) or one barrier method (e.g. diaphragm with spermicide, intrauterine device, cervical cap). Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests at the study baseline and on each scan day appointment prior to the MRI scan.

  • Healthy Control Participants:

    (i) no current DSM diagnosis (by clinician interview confirmed by SCID or MINI); (ii) no documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.

Exclusion Criteria:

  • Exclusion criteria for all groups will include:

    (i) any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment; (ii) any substance use disorder within the past 6 months; (iii) use of psychotropic medications within the past 8 weeks, with the exception of occasional use of a sleep aid or analgesic; (iv) use of an as-needed sleep aid or prescription analgesic within 3 days of the scan; (v) any history of a primary psychotic disorder or of mania; (vi) any evidence of substance use on urine toxicology testing; (vii) any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness; (viii) pregnancy; (ix) any metal in the body or other contraindication to MRI scanning; (x) severe claustrophobia, back pain, or other condition that may make an extended MR scan difficult or lead to excessive movement during the scan.

  • Additional exclusion criteria:

  • OCD Participants:

    (i) past allergy or adverse reaction to fluoxetine or another SSRI, or other clinical contraindication to fluoxetine pharmacotherapy; (ii) documented nonresponse to a past trial of fluoxetine of appropriate dose (≥40 mg/dy) and duration (≥12 weeks).

(iii) Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Healthy Controls

The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline.

Eksperimentel: OCD Group

The OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy.

Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.

Andre navne:
  • fluoxetin, prozac

Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.

Andre navne:
  • fluoxetin, prozac

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Obsessive-compulsive severity change
Tidsramme: 18 weeks

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS);72,73 -This is a checklist and Clinician administered - 10 item severity scale, from none to extreme. Total severity score range is 0 to 40. This will be presented as % improvement in Y-BOCS as a continuous measure of treatment response, rather than an artificially dichotomized measure of 'response', in all analyses. This the primary outcome measure of change across the study treatment and scans.

18 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tic severity change
Tidsramme: 18 weeks

Yale Global Tic Severity Scale (YGTSS) will be used to measure Tic severity. It is a clinician administered instrument with a score from 0 to 25- 25 being the most severe.

18 weeks
Beck Depression Inventory-II
Tidsramme: 18 weeks

Beck Depression Inventory-II (BDI-II);82 21 items to assess intensity of depression.

18 weeks
Anxiety
Tidsramme: 18 weeks

Beck Anxiety Inventory (BAI);83 21 item self report on a 4 point Likert scale - 0 (not at all) to 3 (severely).

18 weeks
Obsessive-compulsive concerns
Tidsramme: 18 weeks

Dimensional Obsessive-Compulsive Scale (DOCS);84 20 questions, asks about 4 categories of obsessive-compulsive concerns (each consists of 5 items scored on a Likert scale of 0-no symptoms to 4 - extreme symptoms) over the previous month.

18 weeks
Magical ideation
Tidsramme: 18 weeks

Magical Ideation Scale (MIS);86 30 item true / false scale, assessing erroneous beliefs based on magical thinking.

18 weeks
Sensory phenomena
Tidsramme: 18 weeks

University of São Paulo Sensory Phenomena Scale (USP-SPS);87

18 weeks
"Not Just Right" experiences and sensations in OCD
Tidsramme: 18 weeks

Not Just Right Experiences Questionnaire Revised (INC).88 19 Questions: Rate 10 NJR Experiences; Choose most recent one; Identify how long ago it occurred; then complete 7 dimensional ratings of that NJRE: frequency, intensity, immediate distress, delayed distress, rumination, urge to respond, and responsibility to do something about the NJRE, from 1 (absence) to 7 (extreme level /or within the past day).

18 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Christopher Pittenger, MD, PhD, Professor of Psychiatry; Director, Yale OCD Research Clinic

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)

14. oktober 2019

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

16. oktober 2019

Først indsendt, der opfyldte QC-kriterier

16. oktober 2019

Først opslået (Faktiske)

18. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2000023688
  • 1R01MH116038-01A1 (U.S. NIH-bevilling/kontrakt)
  • 1K24MH121571-01 (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

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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 .