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
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospitals Cleveland Medical Center* | Cleveland | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.