Clinical trial NCT04528095: SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Official title: Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Treatment-resistant Schizophrenia
Keywords: Schizophrenia
Treatment-resistant
Antipsychotics
Combination
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.

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 treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.

Eligibility criteria: Inclusion Criteria:

1. meet the DSM-5 diagnostic criteria for schizophrenia,
2. be 18-55 years of age,
3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
4. Informed consent.

Exclusion Criteria:

1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
2. Patients with contraindications to even one of the proposed treatment arms are excluded.
3. Patients with risks such as extreme agitation, stupor or suicide are excluded.
4. Female patients with pregnancy or breast-feeding are also excluded.

Primary outcomes:
measure: Response rate
timeFrame: Change from baseline PANSS score at 12 weeks
Secondary outcomes:
measure: Adverse reactions
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Adverse reactions
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Adverse reactions
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Neurocognitive assessments and social function
timeFrame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Neurocognitive assessments and social function
timeFrame: baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months
measure: Clinical assessements
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Clinical assessements
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Clinical assessements
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
measure: Clinical assessements
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Dengtang Liu, MD
role: STUDY_CHAIR
References: