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Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals

NCT ID: NCT03790085

Last Updated: 2018-12-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-31

Brief Summary

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This study aims to screen and validate multi-scale bio-markers for early diagnosis and medication monitoring for early schizophrenia, including the genetic, neurobiochemistry, neuroimaging and eletrophysiological measures. Based on the validated bio-markers, the present study further tries to build several prediction models for early differential diagnosis of schizophrenia from healthy controls and other mental diseases (such as the major depression and anxiety disorders), biological sub-typing and diagnosis of the schizophrenia sub-types, and early prediction of the medication effects.

Detailed Description

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Schizophrenia is one of the most important diseases that threaten the health of Chinese people. In view of the current lack of objective biological markers in the diagnosis and treatment of schizophrenia, as well as the lack of effective early diagnosis methods and curative effect prediction methods, the investigators carried out joint research by integrating research teams from molecular genetics, neurobiochemistry, psychiatry, medical imaging, information science and other fields. The overall objective of the project is to establish a bio-marker system for individualized diagnosis and treatment of early schizophrenia. Specific research contents include: screening and verifying multidimensional objective biological markers such as genetics, neurobiochemistry, neuroimaging, electrophysiology, which is related to early diagnosis and efficacy prediction of schizophrenia through big data analysis of healthy controls and patients with first episode schizophrenia, depression and anxiety disorder. Pattern recognition method is used to build the individualized early diagnosis model, biological sub-type clustering model, biological sub-type individualized diagnosis model and early curative effect prediction model of schizophrenia. Based on the individualized diagnosis and treatment prediction model of schizophrenia, the individualized diagnosis and treatment toolkit was developed, and the individualized diagnosis and treatment prediction cloud platform was established to provide assist for clinicians.

Conditions

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Schizophrenia Major Depressive Disorder Anxiety Disorders

Keywords

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Precision medicine Bio-marker Neuroimaging Molecular genetics Neurobiochemical Early diagnosis Early prediction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Risperidone

It can be used after schizophrenia is diagnosed. Risperidone affects prolactin and may affect menstruation in young women, so we will try not to use it in such patients. Patients were randomized to a single Risperidone control trial for 8 weeks to evaluate the clinical efficacy of the patients. Risperidone routine daily 2-6 mg, up to 8 mg, can be taken orally twice a day.

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Risperidone tablet

Olanzapine

It can be used after schizophrenia is diagnosed. Olanzapine is not generally used in patients with diabetes and hyperlipidemia. Patients were randomized to a single Olanzapine control trial for 8 weeks to evaluate the clinical efficacy of the patients. Olanzapine is available once or twice a day, starting at 5 mg daily and up to 20 mg daily.

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

Olanzapine tablet

Aripiprazole

It can be used after schizophrenia is diagnosed. Aripiprazole has no specific contraindications. Patients were randomized to a single Aripiprazole control trial for 8 weeks to evaluate the clinical efficacy of the patients. Aripiprazole is taken orally once a day, starting at 10 mg daily and up to 30 mg daily.

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Aripiprazole tablet

Interventions

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Risperidone

Risperidone tablet

Intervention Type DRUG

Olanzapine

Olanzapine tablet

Intervention Type DRUG

Aripiprazole

Aripiprazole tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* According with American mental disorder diagnosis and Diagnostic criteria for schizophrenia, major depressive disorder, and anxiety disorder in the statistical manual DSM-IV
* The time from the onset of symptoms for the first time to participate in study is less than 12 months
* No any anti-psychotic drugs or medication was taken more than 14 days
* Han nationality
* 18 to 45 years old
* Right-handed


* Han nationality
* Right-handedness
* Gender, age and education level are matched with patients
* 18 to 45 years old
* Any mental disorder diagnosis in DSM-IV was excluded
* There were no relatives with severe mental disorder in the two or three generations

Exclusion Criteria

* The patient has other psychiatric disorder beside the illness
* A history of psychoactive substance use, accompanied by severe physical disease
* Have a history of epilepsy or coma
* Women who are pregnant or breast-feeding
* Accompanied by metal implants, claustrophobia and other contraindications of MRI scan
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Tianjin Anding Hospital

OTHER

Sponsor Role collaborator

Harbin First Specialist Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Anhui Mental Health Center

UNKNOWN

Sponsor Role collaborator

Wuhan Psychiatric Hospital

UNKNOWN

Sponsor Role collaborator

Wenzhou Seventh People's Hospital

OTHER_GOV

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunshui Yu

Vice president of Tianjin Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunshui Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

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Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunshui Yu, MD

Role: CONTACT

Phone: 862260363760

Email: [email protected]

Wen Qin, MD

Role: CONTACT

Phone: 862260363760

Email: [email protected]

Facility Contacts

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Chunshui Yu, MD

Role: primary

Wen Qin, MD

Role: backup

References

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Gusev A, Mancuso N, Won H, Kousi M, Finucane HK, Reshef Y, Song L, Safi A; Schizophrenia Working Group of the Psychiatric Genomics Consortium; McCarroll S, Neale BM, Ophoff RA, O'Donovan MC, Crawford GE, Geschwind DH, Katsanis N, Sullivan PF, Pasaniuc B, Price AL. Transcriptome-wide association study of schizophrenia and chromatin activity yields mechanistic disease insights. Nat Genet. 2018 Apr;50(4):538-548. doi: 10.1038/s41588-018-0092-1. Epub 2018 Apr 9.

Reference Type RESULT
PMID: 29632383 (View on PubMed)

Zhu J, Zhuo C, Xu L, Liu F, Qin W, Yu C. Altered Coupling Between Resting-State Cerebral Blood Flow and Functional Connectivity in Schizophrenia. Schizophr Bull. 2017 Oct 21;43(6):1363-1374. doi: 10.1093/schbul/sbx051.

Reference Type RESULT
PMID: 28521048 (View on PubMed)

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.

Reference Type RESULT
PMID: 27918562 (View on PubMed)

Jaffe AE, Gao Y, Deep-Soboslay A, Tao R, Hyde TM, Weinberger DR, Kleinman JE. Mapping DNA methylation across development, genotype and schizophrenia in the human frontal cortex. Nat Neurosci. 2016 Jan;19(1):40-7. doi: 10.1038/nn.4181. Epub 2015 Nov 30.

Reference Type RESULT
PMID: 26619358 (View on PubMed)

Marshall CR, Howrigan DP, Merico D, Thiruvahindrapuram B, Wu W, Greer DS, Antaki D, Shetty A, Holmans PA, Pinto D, Gujral M, Brandler WM, Malhotra D, Wang Z, Fajarado KVF, Maile MS, Ripke S, Agartz I, Albus M, Alexander M, Amin F, Atkins J, Bacanu SA, Belliveau RA Jr, Bergen SE, Bertalan M, Bevilacqua E, Bigdeli TB, Black DW, Bruggeman R, Buccola NG, Buckner RL, Bulik-Sullivan B, Byerley W, Cahn W, Cai G, Cairns MJ, Campion D, Cantor RM, Carr VJ, Carrera N, Catts SV, Chambert KD, Cheng W, Cloninger CR, Cohen D, Cormican P, Craddock N, Crespo-Facorro B, Crowley JJ, Curtis D, Davidson M, Davis KL, Degenhardt F, Del Favero J, DeLisi LE, Dikeos D, Dinan T, Djurovic S, Donohoe G, Drapeau E, Duan J, Dudbridge F, Eichhammer P, Eriksson J, Escott-Price V, Essioux L, Fanous AH, Farh KH, Farrell MS, Frank J, Franke L, Freedman R, Freimer NB, Friedman JI, Forstner AJ, Fromer M, Genovese G, Georgieva L, Gershon ES, Giegling I, Giusti-Rodriguez P, Godard S, Goldstein JI, Gratten J, de Haan L, Hamshere ML, Hansen M, Hansen T, Haroutunian V, Hartmann AM, Henskens FA, Herms S, Hirschhorn JN, Hoffmann P, Hofman A, Huang H, Ikeda M, Joa I, Kahler AK, Kahn RS, Kalaydjieva L, Karjalainen J, Kavanagh D, Keller MC, Kelly BJ, Kennedy JL, Kim Y, Knowles JA, Konte B, Laurent C, Lee P, Lee SH, Legge SE, Lerer B, Levy DL, Liang KY, Lieberman J, Lonnqvist J, Loughland CM, Magnusson PKE, Maher BS, Maier W, Mallet J, Mattheisen M, Mattingsdal M, McCarley RW, McDonald C, McIntosh AM, Meier S, Meijer CJ, Melle I, Mesholam-Gately RI, Metspalu A, Michie PT, Milani L, Milanova V, Mokrab Y, Morris DW, Muller-Myhsok B, Murphy KC, Murray RM, Myin-Germeys I, Nenadic I, Nertney DA, Nestadt G, Nicodemus KK, Nisenbaum L, Nordin A, O'Callaghan E, O'Dushlaine C, Oh SY, Olincy A, Olsen L, O'Neill FA, Van Os J, Pantelis C, Papadimitriou GN, Parkhomenko E, Pato MT, Paunio T; Psychosis Endophenotypes International Consortium; Perkins DO, Pers TH, Pietilainen O, Pimm J, Pocklington AJ, Powell J, Price A, Pulver AE, Purcell SM, Quested D, Rasmussen HB, Reichenberg A, Reimers MA, Richards AL, Roffman JL, Roussos P, Ruderfer DM, Salomaa V, Sanders AR, Savitz A, Schall U, Schulze TG, Schwab SG, Scolnick EM, Scott RJ, Seidman LJ, Shi J, Silverman JM, Smoller JW, Soderman E, Spencer CCA, Stahl EA, Strengman E, Strohmaier J, Stroup TS, Suvisaari J, Svrakic DM, Szatkiewicz JP, Thirumalai S, Tooney PA, Veijola J, Visscher PM, Waddington J, Walsh D, Webb BT, Weiser M, Wildenauer DB, Williams NM, Williams S, Witt SH, Wolen AR, Wormley BK, Wray NR, Wu JQ, Zai CC, Adolfsson R, Andreassen OA, Blackwood DHR, Bramon E, Buxbaum JD, Cichon S, Collier DA, Corvin A, Daly MJ, Darvasi A, Domenici E, Esko T, Gejman PV, Gill M, Gurling H, Hultman CM, Iwata N, Jablensky AV, Jonsson EG, Kendler KS, Kirov G, Knight J, Levinson DF, Li QS, McCarroll SA, McQuillin A, Moran JL, Mowry BJ, Nothen MM, Ophoff RA, Owen MJ, Palotie A, Pato CN, Petryshen TL, Posthuma D, Rietschel M, Riley BP, Rujescu D, Sklar P, St Clair D, Walters JTR, Werge T, Sullivan PF, O'Donovan MC, Scherer SW, Neale BM, Sebat J; CNV and Schizophrenia Working Groups of the Psychiatric Genomics Consortium. Contribution of copy number variants to schizophrenia from a genome-wide study of 41,321 subjects. Nat Genet. 2017 Jan;49(1):27-35. doi: 10.1038/ng.3725. Epub 2016 Nov 21.

Reference Type RESULT
PMID: 27869829 (View on PubMed)

Lei X, Ren J, Teng X, Guo C, Wu Z, Yu L, Chen X, Fu L, Zhang R, Wang D, Chen Y, Zhang Y, Zhang C. Characterizing Unipolar and Bipolar Depression by Alterations in Inflammatory Mediators and the Prefrontal-Limbic Structural Network. Depress Anxiety. 2023 May 24;2023:5522658. doi: 10.1155/2023/5522658. eCollection 2023.

Reference Type DERIVED
PMID: 40224600 (View on PubMed)

Fu L, Ren J, Lei X, Wang Y, Chen X, Zhang R, Li Q, Teng X, Guo C, Wu Z, Yu L, Wang D, Chen Y, Qin J, Yuan A, Zhang C. Association of anhedonia with brain-derived neurotrophic factor and interleukin-10 in major depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2024 Jul 13;133:111023. doi: 10.1016/j.pnpbp.2024.111023. Epub 2024 May 1.

Reference Type DERIVED
PMID: 38701878 (View on PubMed)

Lei X, Fang X, Ren J, Teng X, Guo C, Wu Z, Yu L, Wang D, Chen Y, Zhou Y, Wu Y, Zhang Y, Zhang C. Plasma Apo-E mediated corticospinal tract abnormalities and suicidality in patients with major depressive disorder. Eur Arch Psychiatry Clin Neurosci. 2024 Aug;274(5):1167-1175. doi: 10.1007/s00406-023-01749-w. Epub 2024 Jan 24.

Reference Type DERIVED
PMID: 38265467 (View on PubMed)

Other Identifiers

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2018YFC1314300

Identifier Type: -

Identifier Source: org_study_id