Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients
Condition: Treatment-resistant Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      This study includes two main components: the first screening phase and the second clinical
      intervention phase. During the screening phase, subjects with poor response to clozapine are
      carefully evaluated by chart-review and clinical assessment. Via chart-review, clinical data
      of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic
      agents are obtained. Clinical phenomenology, including psychopathology, psychotic and mood
      symptoms severity and side effect of psychotropic medication are assessed by clinical
      interview and observation, which are conducted by experienced clinicians. Blood sample will
      be also obtained from the subjects for measuring the baseline clozapine drug level and
      extracting DNA for further analysis. Subjects fulfilling the criteria of treatment-resistant
      schizophrenia with poor response to adequate dose and duration of clozapine treatment are
      eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride
      add-on study. In this phase, subjects are randomly allocated to amisulpride augmentation
      treatment group and placebo treatment group. Subjects in the former group will receive
      clozapine and amisulpride combination treatment, while in the latter group will receive
      clozapine and placebo. Outcomes of clinical efficacy and safety are carefully evaluated by
      experienced and well-trained research stuffs in the 14 weeks of clinical study period.

      All of the above studies will be conducted in four hospitals, including DOH Bali Psychiatric
      Hospital, DOH Tao-yan Psychiatric hospital, and the Ju-Shang Psychiatric Hospital. Subjects
      will be recruited from the chronic in-patient settings from these three hospitals.
    


Intervention name(s): Amisulpride add-on; Placebo add-on
Intervention type(s): Drug; Drug
Intervention description(s): At the beginning of the treatment phase (day 1), subjects in the combination treatment group will be started with adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. All of the add-on amisulpride will be provided to subjects at night. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.; For subjects randomly allocated to the placebo treatment group, they will be added with one capsule of placebo from Day 1. On Day 8, Day 15 and Day 22, the placebo will be increased to 2, 3 and 4 capsules, respectively. and adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: treatment-resistant schizophrenia; clozapine; amisulpride