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NCT05186077Leállítva

Brain Circuitry Analysis in Bipolar Disorder

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 6.

Megadott ok: The original funding for this study ended and we were not able to secure new funding to continue

Rövid összefoglaló (regiszter, angolul)

The goal of this cross-sectional study is to use diffusion-weighted imaging based tractography (DWT) to assess white matter (WM) pathways in treatment-refractory bipolar disorder (REF-BD) and treatment responsive bipolar disorder (RSP-BD) subjects compared to healthy controls (HCs). This project will include a prospective controlled trial to include 50 subjects with REF-BD, 50 patients RSP-BD and 50 healthy volunteers.

Állapot (regiszter)
Leállítva
Vizsgálattípus
Megfigyeléses
Résztvevők száma
26 (tényleges)
Első benyújtás
2021. dec. 23.
Kezdés
2020. okt. 15.
Elsődleges befejezés
2025. júl. 31.
Fő szponzor
Jennifer Sweet
Betegségek
Bipoláris zavar
NCT-szám
NCT05186077

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
  • Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
  • Use of stimulants 24 hours prior MRI visit
  • Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
  • Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
  • Has had changes in medications within 30 days
  • Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
  • Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
  • Has had changes in medications within 30 days

Más betegség

  • Acute medical condition or >3 stable, chronic health conditions
  • Progressive neurological disease
  • Has psychiatric disorder, including alcohol/drug use disorder or personality disorder
    • Group 2: Treatment-Responsive BDI
  • Acute medical condition or >3 stable, chronic health conditions
  • Progressive neurological disease
  • Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
  • Meets DSM-5 criteria for current borderline or antisocial personality disorder
  • Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
    • Group 3: Treatment-Refractory BDI
  • Acute medical condition or >3 stable, chronic health conditions
  • Progressive neurological disease
  • Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
  • Meets DSM-5 criteria for current borderline or antisocial personality disorder
  • Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine

Egyéb

  • Significant structural brain lesion
  • Preexisting implanted electrical device
  • Currently pregnant or planning to become pregnant
  • Contraindications to MR imaging
  • Use of cigarettes or other nicotine products within 12 hours of imaging visit
  • Presents an immediate danger to self or others as judged by research psychiatrist
  • Significant structural brain lesion
  • Preexisting implanted electrical device
  • Currently pregnant or planning to become pregnant
  • Contraindications to MR imaging
  • Use of cigarettes or other nicotine products within 12 hours of imaging visit
  • Use of stimulants within 24 hours of imaging visit
  • Presents an immediate danger to self or others as judged by research psychiatrist
  • Significant structural brain lesion
  • Preexisting implanted electrical device
  • Currently pregnant or planning to become pregnant
  • Contraindications to MR imaging
  • Use of cigarettes or other nicotine products within 12 hours of imaging visit
  • Use of stimulants within 24 hours of imaging visit
  • Presents an immediate danger to self or others as judged by research psychiatrist

Kiket keres a vizsgálat

  • Male or female ≥18 years of age
  • Capable of understanding/complying with protocol requirements
  • Has competency to understand and sign informed consent form
  • Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
  • Without current and/or lifetime psychiatric disorders as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
  • Male or female ≥18 years of age
  • Capable of understanding/complying with protocol requirements
  • Has competency to understand and sign informed consent form
  • Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
  • Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
  • Must be stable on current BD medications with no dosing changes in the last 30 days or not currently taking any BD medications.
  • Recent mood episode must currently be in remission for > 8 weeks
  • Montgomery-Asberg Depression Rating Scale (MADRS) ≤10 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
  • Young Mania Rating Scale (YMRS) ≤12 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
  • Clinical Global Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤2 during the psychiatric assessments visit
  • Must be adherent (≥ 80%) with BD medication(s)
  • Male or female ≥18 years of age
  • Capable of understanding/complying with protocol requirements
  • Has competency to understand and sign informed consent form
  • Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
  • Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
  • Must be stable on drugs, including at least 1 mood stabilizer, with no dosing changes in the last 30 days
  • GCI-S-BD >3 at the psychiatric assessments visit
  • MADRS ≥20 total score or YMRS ≥18 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
  • BD-associated mood episodes are primary source of disability, according to both subject and psychiatrist
  • Current depressive episode lasting ≥6 months despite ≥ 2 adequate evidence-based first-line treatment > 8 weeks, current manic/hypomanic episode lasting ≥2 months despite ≥ 2 adequate evidence-based first-line treatment > 4 weeks, or meeting rapid cycling criteria in last 12 months despite ≥2 evidence-based first-line treatments for BDI or BDII assessed with assistance of Modified Antidepressant Treatment History Form (MATHF)
  • Severe impairment with score of ≥7 on at least one of three subscales of Sheehan Disability Scale (SDS), which includes assessment of work-life, family-life, and social life during the psychiatric assessments portion

A regiszterben nem jelölt feltételek

  • Group 1: Healthy Volunteers

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University Hospitals Cleveland Medical Center*ClevelandEgyesült ÁllamokIsmeretlen állapot

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