Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-03-01
2020-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy subjects
50 healthy subjects for a control group
SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Patients with Major Depression
50 patients with major depression for a research group
SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Interventions
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SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female
3. Ability to comprehend and sign informed consent
4. DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)
1. DSM-5 diagnosis
2. 0-2 failed treatments
3. Patients which will start SSRI treatment
Exclusion Criteria
2. Pregnancy or nursing
3. Cardiovascular instability
4. Metabolic instability (water, electrolytes, sugar)
5. Fever or evidence of microbiological pollutant
6. Deafness or blindness
7. Schizophrenia
8. Addiction disorders
9. Eating disorders
10. Bi-polar disorder
11. Cognitive deficits
12. Start a new psychotherapy during the research
13. Unable to enter the MRI scanner
18 Years
65 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Hebrew University of Jerusalem
OTHER
ElMindA Ltd
INDUSTRY
Responsible Party
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Locations
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Sheba Medical CENTER
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5.
Ogawa T, Sekino H, Uzura M, Sakamoto T, Taguchi Y, Yamaguchi Y, Hayashi T, Yamanaka I, Oohama N, Imaki S. Comparative study of magnetic resonance and CT scan imaging in cases of severe head injury. Acta Neurochir Suppl (Wien). 1992;55:8-10. doi: 10.1007/978-3-7091-9233-7_3.
Raichle ME, Snyder AZ. A default mode of brain function: a brief history of an evolving idea. Neuroimage. 2007 Oct 1;37(4):1083-90; discussion 1097-9. doi: 10.1016/j.neuroimage.2007.02.041. Epub 2007 Mar 6.
Rohden AI, Benchaya MC, Camargo RS, Moreira TC, Barros HMT, Ferigolo M. Dropout Prevalence and Associated Factors in Randomized Clinical Trials of Adolescents Treated for Depression: Systematic Review and Meta-analysis. Clin Ther. 2017 May;39(5):971-992.e4. doi: 10.1016/j.clinthera.2017.03.017. Epub 2017 May 2.
Other Identifiers
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ELM-55 5323-18-SMC
Identifier Type: -
Identifier Source: org_study_id
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