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Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group
| Condition or disease |
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| Schizophrenia |
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group |
| Actual Study Start Date : | November 1, 2016 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2022 |
| Group/Cohort |
|---|
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Ultra-high risk for psychosis (UHP)
Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Inclusion Criteria: age of 13-30 years; meet the diagnostic criteria of COPS prodromal syndrome by SIPS clinical interviews; have not received any psychiatric medication; be in good health, without major mental illness or physical illness; normal intelligence, can be operated on a clinical scale; volunteer to participate in the study and sign the written consent form. Exclusion criteria: exclusion of current or previous psychiatric disorders by SCID interview; meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV; contraindications for MRI; pregnant or lactating women. |
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Healthy controls
Inclusion Criteria: the gender, age, and education level of the group are matched with the Ultra-high risk group; 13 to 30 years old; right-handed; no history of mental illness; no mental disorder consistent with DSM-IV diagnostic criteria within two or three generations; No contraindications for MRI; volunteer to participate in the study and sign the written consent form. Exclusion criteria: history of disturbance of consciousness over 5 minutes; history of brain organic disease or head injury; history of alcohol and drug dependence; history of coma; history of endocrine disease; abnormity in examination of blood, heart, liver, or renal function; pregnant or lactating women. |
- Conversion to psychosis. [ Time Frame: Two years. ]Conversion is operationalized as the criteria of POPS (Presence of Psychotic Symptoms in SIPS/SOPS). Subjects have to demonstrate at least one psychotic level symptom (rated a '6') on at least one of the five P(Positive) symptoms (P1, unusual thought content; P2, suspiciousness; P3, grandiosity; P4, perceptual abnormalities; and P5, disorganized communication), with either sufficient frequency and duration or at a level that is disorganizing or dangerous.
Biospecimen Retention: Samples With DNA
| Ages Eligible for Study: | 13 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 1. age of 13-30 years;
- 2. meet the diagnostic criteria of COPS prodromal syndrome by SIPS clinical interviews;
- 3. have not received any psychiatric medication;
- 4. be in good health, without major mental illness or physical illness;
- 5. normal intelligence, can be operated on a clinical scale;
- 6. volunteer to participate in the study and sign the written consent form.
Exclusion Criteria:
- 1. exclusion of current or previous psychiatric disorders by SCID interview;
- 2. meet the diagnostic criteria for substance abuse and substance dependence in DSM-IV;
- 3. contraindications for MRI;
- 4. pregnant or lactating women.
| Contact: Xiaogang Chen, Ph.D | (+86)0731-85531571 | Chenxiaogang@csu.edu.cn | |
| Contact: Ying He, Ph.D | (+86)0731-85531571 | yinghe@csu.edu.cn |
| China, Hunan | |
| The 2nd Xiangya Hospital of Central South University | Recruiting |
| Changsha, Hunan, China, 410011 | |
| Contact: Xiaogang Chen, Ph.D (+86)0731-85531571 Chenxiaogang@csu.edu.cn | |
| Contact: Ying He, Ph.D (+86)0731-85531571 yinghe@csu.edu.cn | |
| Principal Investigator: | Xiaogang Chen, Ph.D | Professor |
| Tracking Information | |||||||||
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| First Submitted Date | May 26, 2019 | ||||||||
| First Posted Date | May 29, 2019 | ||||||||
| Last Update Posted Date | May 29, 2019 | ||||||||
| Actual Study Start Date | November 1, 2016 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Conversion to psychosis. [ Time Frame: Two years. ] Conversion is operationalized as the criteria of POPS (Presence of Psychotic Symptoms in SIPS/SOPS). Subjects have to demonstrate at least one psychotic level symptom (rated a '6') on at least one of the five P(Positive) symptoms (P1, unusual thought content; P2, suspiciousness; P3, grandiosity; P4, perceptual abnormalities; and P5, disorganized communication), with either sufficient frequency and duration or at a level that is disorganizing or dangerous.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group | ||||||||
| Official Title | Study on Predictiors and Mechanism of Conversion to Psychosis in Individuals at Ultra-high Risk Group | ||||||||
| Brief Summary | Considering the complex pathological mechanism and the poor treatment outcomes of schizophrenia, early detection and intervention gradually become the key work for the foundational and clinical research in schizophrenia. Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. Early intervention in individual at UHP can effectively delay or even prevent the development of the illness. Long-term longitudinal studies suggested that there are clinical outcomes in people at UHP. Nearly 1/3 of individuals at UHP may be naturally relieved without any intervention, about 1/3 of individuals at UHP will remain at the prodromal stage of schizophrenia, and only 1/3 individuals at UHP will eventually develop schizophrenia. In this regard, it will cause adverse effects on false positive individuals if they accept clinical intervention. Unfortunately, it is difficult to accurately predict which individuals at UHP will make a transition to frank illness. To solve this issue, we explore the association between baseline brain structural and functional networks, methylation modifications, gene expression, neurocognitive function and the clinical outcomes of UHP individuals, and to identify the potential biological and clinical predictors for the long-term outcomes in the individuals at UHP. In addition, we also detect the changes of brain structure and function, methylation status and gene expression in individuals at UHP during follow-up, and further to investigate the etiology and pathogenesis of schizophrenia. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Genomic DNA and RNA will be extracted respectively from white blood cells in peripheral blood.
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Ultra-high risk for psychosis (UHP) is defined as individuals at the prodromal stage of schizophrenia. | ||||||||
| Condition | Schizophrenia | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2022 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 13 Years to 30 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT03965598 | ||||||||
| Other Study ID Numbers | 81871056 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Xiaogang Chen, Second Xiangya Hospital of Central South University | ||||||||
| Study Sponsor | Second Xiangya Hospital of Central South University | ||||||||
| Collaborators | Sun Yat-sen University | ||||||||
| Investigators |
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| PRS Account | Second Xiangya Hospital of Central South University | ||||||||
| Verification Date | May 2019 | ||||||||
