NCT04010864

A Study of Antipsychotics in Individuals at Clinical High-risk for Psychosis (the SHARP-2 Study)

Real-world Effectiveness and Safety of Antipsychotics in Individuals at Clinical High-risk for Psychosis: Study Protocol for a Prospective Observational Study (SHARP-2)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical High-risk

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-29
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-07-08
• Last updated: 2020-10-22

Locations

1 site across 1 country: China