Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
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.