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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010864
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Ministry of Science and Technology of the People´s Republic of China
National Natural Science Foundation of China
Shanghai Municipal Science and Technology Commission
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Tianhong ZHANG, Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment
Clinical High-risk Other: routine clinical 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.

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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
whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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.
Criteria

Inclusion Criteria:

  • be aged 14 to 45-year-old
  • have had at least 6-years of primary education
  • be drug-naïve
  • be understanding the survey, be willing to enrol in the study and sign the informed consent
  • Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome

Exclusion Criteria:

  • Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders will be excluded
  • Acute or chronic renal failure; liver cirrhosis or active liver diseases
  • Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects
  • Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L
  • Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial
  • Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial
  • Stroke within the last month
  • Participating in any clinical trial within 30 days before the baseline
  • Other situations judged by the investigators not to be suitable for the clinical trial

Information from the National Library of Medicine

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


Contacts
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Contact: TianHong Zhang, Doctor 13127577024 zhang_tianhong@126.com

Locations
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China
Shanghai Mental Health Center Recruiting
Shanghai, China
Contact: TianHong Zhang, Doctor    13127577024    zhang_tianhong@126.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Ministry of Science and Technology of the People´s Republic of China
National Natural Science Foundation of China
Shanghai Municipal Science and Technology Commission
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: TianHong Zhang, Doctor Shanghai Mental Health Center
Publications:

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Responsible Party: Tianhong ZHANG, associate research fellow, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04010864    
Other Study ID Numbers: CRC2018ZD04
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders