Status:
UNKNOWN
A Study of Antipsychotics in Individuals at Clinical High-risk for Psychosis (the SHARP-2 Study)
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
National Natural Science Foundation of China
Conditions:
Clinical High-risk
Eligibility:
All Genders
14-45 years
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 opti...
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 conse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04010864
Start Date
March 29 2019
End Date
December 1 2022
Last Update
October 22 2020
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, China