Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
| National Natural Science Foundation of China | OTHER_GOV |
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The current study will improve knowledge on the effectiveness and safety of the use of antipsychotics at the prodromal phase and on factors influencing the outcome, and will eventually facilitate optimisation of individualised interventions for psychosis prevention and treatment.
Help-seeking first-visit participants will be consecutively recruited. Every participant meeting the inclusion criteria will be fully informed of the study and asked to sign the written informed consent before enrolment.
Two senior nurses that will conduct the initial screenings were employed to collect all diagnostic and medication information from medical records on every follow-up visit. The four psychiatrists are qualified and well-trained and will conduct the SIPS/SOPS interview at baseline and follow-up.
The investigators will systematically record medication information. A model will be established to correlate antipsychotics with clinical and functional outcomes and demonstrate whether antipsychotics are useful and safe for preventing CHR individuals from converting to psychosis.
Based on experience from the sampling process in the SHARP-1 project, the investigators will recruit 600 participants at CHR. Considering a dropout rate of 20%, 510 cases of CHR will be followed up. According to the sample size calculation formula in superiority clinical trials of new drugs, the sample size of 600 cases is adequate for the demonstration of the effectiveness and safety of antipsychotics in CHR subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHARP-2 | ShangHai At Risk for Psychosis-Phase 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| routine clinical treatment | Other | Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to psychosis | It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours. | 4 weeks |
| Poor function | It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point. | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Help-seeking first-visit participants will be consecutively recruited from the Shanghai Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre. They will be screened for eligibility by their clinicians.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TianHong Zhang, Doctor | Contact | 13127577024 | zhang_tianhong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| TianHong Zhang, Doctor | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23165428 | Background | Fusar-Poli P, Borgwardt S, Bechdolf A, Addington J, Riecher-Rossler A, Schultze-Lutter F, Keshavan M, Wood S, Ruhrmann S, Seidman LJ, Valmaggia L, Cannon T, Velthorst E, De Haan L, Cornblatt B, Bonoldi I, Birchwood M, McGlashan T, Carpenter W, McGorry P, Klosterkotter J, McGuire P, Yung A. The psychosis high-risk state: a comprehensive state-of-the-art review. JAMA Psychiatry. 2013 Jan;70(1):107-20. doi: 10.1001/jamapsychiatry.2013.269. | |
| 23739772 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shanghai Jiao Tong University School of Medicine | OTHER |
Not provided
Not provided
Not provided
whole blood
| Background |
| Nelson B, Yuen HP, Wood SJ, Lin A, Spiliotacopoulos D, Bruxner A, Broussard C, Simmons M, Foley DL, Brewer WJ, Francey SM, Amminger GP, Thompson A, McGorry PD, Yung AR. Long-term follow-up of a group at ultra high risk ("prodromal") for psychosis: the PACE 400 study. JAMA Psychiatry. 2013 Aug;70(8):793-802. doi: 10.1001/jamapsychiatry.2013.1270. |
| 11067646 | Background | Lindstrom E, Bingefors K. Patient compliance with drug therapy in schizophrenia. Economic and clinical issues. Pharmacoeconomics. 2000 Aug;18(2):106-24. doi: 10.2165/00019053-200018020-00002. |
| 19118320 | Background | Crumlish N, Whitty P, Clarke M, Browne S, Kamali M, Gervin M, McTigue O, Kinsella A, Waddington JL, Larkin C, O'Callaghan E. Beyond the critical period: longitudinal study of 8-year outcome in first-episode non-affective psychosis. Br J Psychiatry. 2009 Jan;194(1):18-24. doi: 10.1192/bjp.bp.107.048942. |
| 29173206 | Background | Zhang T, Xu L, Tang Y, Cui H, Wei Y, Wang J, Tang X, Li C, Wang J. Duration of untreated prodromal symptoms in a Chinese sample at a high risk for psychosis: demographic, clinical, and outcome. Psychol Med. 2018 Jun;48(8):1274-1281. doi: 10.1017/S0033291717002707. Epub 2017 Nov 27. |
| 29942980 | Background | Zhang T, Xu L, Tang Y, Cui H, Tang X, Wei Y, Wang Y, Hu Q, Qian Z, Liu X, Li C, Wang J. Relationship between duration of untreated prodromal symptoms and symptomatic and functional recovery. Eur Arch Psychiatry Clin Neurosci. 2019 Dec;269(8):871-877. doi: 10.1007/s00406-018-0917-z. Epub 2018 Jun 25. |
| 28823722 | Background | Zhang T, Cui H, Wei Y, Tang Y, Xu L, Tang X, Zhu Y, Jiang L, Zhang B, Qian Z, Chow A, Liu X, Li C, Xiao Z, Wang J. Progressive decline of cognition during the conversion from prodrome to psychosis with a characteristic pattern of the theory of mind compensated by neurocognition. Schizophr Res. 2018 May;195:554-559. doi: 10.1016/j.schres.2017.08.020. Epub 2017 Aug 18. |
| 27721394 | Background | Zhang T, Cui H, Tang Y, Xu L, Li H, Wei Y, Liu X, Chow A, Li C, Jiang K, Xiao Z, Wang J. Correlation of social cognition and neurocognition on psychotic outcome: a naturalistic follow-up study of subjects with attenuated psychosis syndrome. Sci Rep. 2016 Oct 10;6:35017. doi: 10.1038/srep35017. |
| 30410064 | Background | Collin G, Seidman LJ, Keshavan MS, Stone WS, Qi Z, Zhang T, Tang Y, Li H, Anteraper SA, Niznikiewicz MA, McCarley RW, Shenton ME, Wang J, Whitfield-Gabrieli S. Functional connectome organization predicts conversion to psychosis in clinical high-risk youth from the SHARP program. Mol Psychiatry. 2020 Oct;25(10):2431-2440. doi: 10.1038/s41380-018-0288-x. Epub 2018 Nov 8. |
| 30087434 | Background | Shakory S, Watts JJ, Hafizi S, Da Silva T, Khan S, Kiang M, Bagby RM, Chavez S, Mizrahi R. Hippocampal glutamate metabolites and glial activation in clinical high risk and first episode psychosis. Neuropsychopharmacology. 2018 Oct;43(11):2249-2255. doi: 10.1038/s41386-018-0163-0. Epub 2018 Jul 28. |
| 20493540 | Background | Rauchensteiner S, Kawohl W, Ozgurdal S, Littmann E, Gudlowski Y, Witthaus H, Heinz A, Juckel G. Test-performance after cognitive training in persons at risk mental state of schizophrenia and patients with schizophrenia. Psychiatry Res. 2011 Feb 28;185(3):334-9. doi: 10.1016/j.psychres.2009.09.003. Epub 2010 May 21. |
| 20124114 | Background | Amminger GP, Schafer MR, Papageorgiou K, Klier CM, Cotton SM, Harrigan SM, Mackinnon A, McGorry PD, Berger GE. Long-chain omega-3 fatty acids for indicated prevention of psychotic disorders: a randomized, placebo-controlled trial. Arch Gen Psychiatry. 2010 Feb;67(2):146-54. doi: 10.1001/archgenpsychiatry.2009.192. |
| 27893018 | Background | McGorry PD, Nelson B, Markulev C, Yuen HP, Schafer MR, Mossaheb N, Schlogelhofer M, Smesny S, Hickie IB, Berger GE, Chen EY, de Haan L, Nieman DH, Nordentoft M, Riecher-Rossler A, Verma S, Thompson A, Yung AR, Amminger GP. Effect of omega-3 Polyunsaturated Fatty Acids in Young People at Ultrahigh Risk for Psychotic Disorders: The NEURAPRO Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):19-27. doi: 10.1001/jamapsychiatry.2016.2902. |
| 12365879 | Background | McGorry PD, Yung AR, Phillips LJ, Yuen HP, Francey S, Cosgrave EM, Germano D, Bravin J, McDonald T, Blair A, Adlard S, Jackson H. Randomized controlled trial of interventions designed to reduce the risk of progression to first-episode psychosis in a clinical sample with subthreshold symptoms. Arch Gen Psychiatry. 2002 Oct;59(10):921-8. doi: 10.1001/archpsyc.59.10.921. |
| 35324095 | Derived | Zeng J, Raballo A, Gan R, Wu G, Wei Y, Xu L, Tang X, Hu Y, Tang Y, Chen T, Li C, Wang J, Zhang T. Antipsychotic Exposure in Clinical High Risk of Psychosis: Empirical Insights From a Large Cohort Study. J Clin Psychiatry. 2022 Mar 21;83(3):21m14092. doi: 10.4088/JCP.21m14092. |