Status:
UNKNOWN
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Treatment-resistant Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of d...
Detailed Description
This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three...
Eligibility Criteria
Inclusion
- meet the DSM-5 diagnostic criteria for schizophrenia,
- be 18-55 years of age,
- treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
- Informed consent.
Exclusion
- Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
- Patients with contraindications to even one of the proposed treatment arms are excluded.
- Patients with risks such as extreme agitation, stupor or suicide are excluded.
- Female patients with pregnancy or breast-feeding are also excluded.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04528095
Start Date
December 1 2020
End Date
December 1 2022
Last Update
August 27 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200030