- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02655978
Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion and Exclusion Criteria for Group 1: Healthy Volunteers
a. Inclusion Criteria for Group 1:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Physically healthy
v. Without any current and/or lifetime psychiatric disorder assessed with a Structured Clinical Interview for psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)
b. Exclusion Criteria for Group 1:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Any psychiatric disorder including any severe personality disorder
v. Currently pregnant or planning to become pregnant
vi. Any other contraindications to the brain imaging procedures.
vii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
viii. Currently taking any steroids, stimulants, or opioid pain killers.
ix. Currently experiencing nicotine dependence or any smoking of cigarettes or use of other nicotine containing products within a week before the imaging visit.
Inclusion and Exclusion Criteria for Group 2: Medically Treatment-Responsive Bipolar Disorder
a. Inclusion Criteria for Group 2:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Meets diagnostic criteria for BDI or BDII according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the MINI
v. A recent episode of depression, currently in remission with evidence-based treatments for bipolar disorder
vi. Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤ 10
vii. Young Mania Rating Scale (YMRS, Young et al 1988) total score ≤ 8
viii. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤ 2
ix. Subject is compliant with taking medication per the investigator's discretion
b. Exclusion Criteria for Group 2:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Contribution of any co-occurring psychiatric comorbidity that is disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
v. Meets criteria for antisocial personality disorder
vi. Meets criteria for having borderline personality disorder
vii. There will be no exclusions based on prescribed CNS-active medications
viii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
ix. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine
x. Currently pregnant or planning to become pregnant
xi. Any other contraindications to the brain imaging procedures.
Inclusion and Exclusion Criteria for Group 3: Treatment-Refractory Bipolar Disorder
a. Inclusion Criteria for Group 3:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Meets diagnostic criteria for BDI or BDII, currently depressed, at least moderately severe with or without psychotic features, according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the Structured Clinical Interview for Psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)
v. Current episode lasting at least 6 months and not responding to 2 adequate evidence-based treatments for BDI or BDII assessed with the assistance of Modified Antidepressant Treatment History Form (MATHF) and verified through medical records if possible
vi. If a subject has refused treatment with a particular FDA-approved mood stabilizer due to reasons of unacceptable side effects (such as weight gain, etc.), their wishes will be respected
vii. Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score ≥ 20 is required at Screening Visit/Baseline Evaluation.
viii. Has experienced marked impairment as documented by a score consistent with severe impairment (7 or more on at least one of the three subscales of the Sheehan Disability Scale (SDS), which includes an assessment of work-life, family-life, and social life (no/mild impairment 0-3, moderate impairment 4-6, severe impairment 7-10)
ix. Bipolar disorder and current depressive episode as the primary source of the patient's disability, according to both the subject and the psychiatrist
b. Exclusion Criteria for Group 3:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Contribution of any co-occurring psychiatric comorbidity that disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
v. Meets criteria for antisocial personality disorder
vi. Meets criteria for having borderline personality disorder
vii. There will be no exclusions based on prescribed CNS-active medications
viii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
ix. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine
x. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years
xi. Currently pregnant or planning to become pregnant
xii. Any other contraindications to the brain imaging procedures.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Healthy Volunteers
These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
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Medically Treatment-Responsive BD
This group will be composed of participants who have BDI or BDII and have most recently been depressed but are currently in remission with evidence-based treatments for bipolar disorder
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Treatment-Refractory BD
This group will be composed of participants who have BDI or BDII, are currently depressed with their current episode lasting at least 12 months and not responding to 4 adequate evidence-based treatments for BDI or BDII and who have failed, been intolerant to, or were unwilling to try electroconvulsive therapy (ECT).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls
Tidsramme: Day 1
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The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences
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Day 1
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennifer A Sweet, MD, University Hospitals Cleveland Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 02-15-35
- KL2TR000440 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Maniodepressiv
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