| Condition or disease | Intervention/treatment |
|---|---|
| Clinical High-risk | Other: routine clinical 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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | Real-world Effectiveness and Safety of Antipsychotics in Individuals at Clinical High-risk for Psychosis: Study Protocol for a Prospective Observational Study (SHARP-2) |
| Actual Study Start Date : | March 29, 2019 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
SHARP-2
ShangHai At Risk for Psychosis-Phase 2
|
Other: routine clinical treatment
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.
|
| Ages Eligible for Study: | 14 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: TianHong Zhang, Doctor | 13127577024 | zhang_tianhong@126.com |
| China | |
| Shanghai Mental Health Center | Recruiting |
| Shanghai, China | |
| Contact: TianHong Zhang, Doctor 13127577024 zhang_tianhong@126.com | |
| Principal Investigator: | TianHong Zhang, Doctor | Shanghai Mental Health Center |
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 4, 2019 | ||||||||||||
| First Posted Date | July 8, 2019 | ||||||||||||
| Last Update Posted Date | October 22, 2020 | ||||||||||||
| Actual Study Start Date | March 29, 2019 | ||||||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures |
|
||||||||||||
| Original Primary Outcome Measures | Same as current | ||||||||||||
| Change History | |||||||||||||
| 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 | A Study of Antipsychotics in Individuals at Clinical High-risk for Psychosis (the SHARP-2 Study) | ||||||||||||
| Official Title | Real-world Effectiveness and Safety of Antipsychotics in Individuals at Clinical High-risk for Psychosis: Study Protocol for a Prospective Observational Study (SHARP-2) | ||||||||||||
| Brief Summary | 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. | ||||||||||||
| Detailed Description |
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. |
||||||||||||
| Study Type | Observational [Patient Registry] | ||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||||||
| Target Follow-Up Duration | 3 Years | ||||||||||||
| Biospecimen | Retention: Samples With DNA Description:
whole blood
|
||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | 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. | ||||||||||||
| Condition | Clinical High-risk | ||||||||||||
| Intervention | Other: routine clinical treatment
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.
|
||||||||||||
| Study Groups/Cohorts | SHARP-2
ShangHai At Risk for Psychosis-Phase 2
Intervention: Other: routine clinical treatment
|
||||||||||||
| 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. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status | Recruiting | ||||||||||||
| Estimated Enrollment |
600 | ||||||||||||
| Original Estimated Enrollment | Same as current | ||||||||||||
| Estimated Study Completion Date | December 2022 | ||||||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Sex/Gender |
|
||||||||||||
| Ages | 14 Years to 45 Years (Child, Adult) | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts |
|
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| Listed Location Countries | China | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number | NCT04010864 | ||||||||||||
| Other Study ID Numbers | CRC2018ZD04 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | Tianhong ZHANG, Shanghai Mental Health Center | ||||||||||||
| Study Sponsor | Shanghai Mental Health Center | ||||||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Shanghai Mental Health Center | ||||||||||||
| Verification Date | October 2020 | ||||||||||||