Schizophrenia Clinical Trial
Official title:
Clozapine Versus Amisulpride Versus Their Combination in the Treatment of Drug-resistant Schizophrenia Patients
Background: schizophrenia is a debilitating mental disorder affecting about 1% of the
general population. About 30% of patients will not react to current drug treatment and
defined as treatment-resistant schizophrenia patients (TRSP). The best studied therapeutic
option for this population is clozapine therapy. Clozapine was shown to be effective than
any other antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not
demonstrated to be more effective than clozapine monotherapy. Albeit Clozapine superiority
in TRSP, its use may be involved with many adverse effects, some of them are
life-threatening, and need for routine blood tests. Amisulpride is an atypical antipsychotic
drug with a different mechanism of action than clozapine, with less adverse effects. No
study compared directly amisulpride and clozapine in TRSP.
Study objective: to compare, for the first time, the broad clinical effectiveness of
clozapine and amisulpride and their combination in TRSP.
Study Design: a clinical, prospective, naturalistic, randomized, comparative study
simulating a real-world approach of clinical decision making.
Methods: a total of 140 TRSP will be recruited from a large regional mental health center.
Participants will be randomized into two treatment groups (70 in each group): clozapine
monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks
of treatment. In case of treatment failure (insufficient clinical response or severe adverse
effect) participants will be offered either to switch to clozapine treatment (for failed
amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine
monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment
will be made using clinician rated scales and self-completed questionnaires, rating the
broad phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive,
cognitive and quality of life) and drug-related adverse effects (objective and subjective).
Analysis: comparison of the effectiveness of the three treatment groups: amisulpride,
clozapine and their combination, in the various dimensions of TRSP.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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