A Study of Antipsychotics in Individuals at Clinical High-risk for Psychosis (the SHARP-2 Study)
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|ClinicalTrials.gov Identifier: NCT04010864|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 22, 2020
|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|
|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|
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.
- Conversion to psychosis [ Time Frame: 4 weeks ]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.
- Poor function [ Time Frame: 4 weeks ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010864
|Contact: TianHong Zhang, Doctoremail@example.com|
|Shanghai Mental Health Center||Recruiting|
|Contact: TianHong Zhang, Doctor 13127577024 firstname.lastname@example.org|
|Principal Investigator:||TianHong Zhang, Doctor||Shanghai Mental Health Center|