Schizophrenia Clinical Trial
Official title:
Switching Antipsychotics: Abrupt Discontinuation Versus Overlap
Clozapine has been demonstrated to be clinically superior to other antipsychotics in treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines. Because it is relegated to use in TRS, guidelines require that it only be used after other antipsychotics have failed; accordingly, clinicians routinely contend with stopping the previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous and potentially severe side effects, the issue of clozapine titration has frequently been addressed, although to our knowledge no study has, as of yet, assessed the comparability of gradual vs. immediate antipsychotic discontinuation in switching to clozapine. To address the gap in knowledge specific to clozapine, the investigators conducted a pilot, 8-week, double-blind, randomized controlled trial examining immediate vs. gradual antipsychotic discontinuation in patients with schizophrenia undergoing a switch to clozapine.
Clozapine has been demonstrated to be clinically superior to other antipsychotics in
treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines.
Because it is relegated to use in TRS, guidelines require that it only be used after other
antipsychotics have failed; accordingly, clinicians routinely contend with stopping the
previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous
and potentially severe side effects, the issue of clozapine titration has frequently been
addressed, although to our knowledge no study has, as of yet, assessed the comparability of
gradual vs. immediate antipsychotic discontinuation in switching to clozapine.
While the question has not been asked vis-à-vis clozapine, there have been several studies
examining gradual vs. immediate antipsychotic discontinuation in switching antipsychotics.
Immediate antipsychotic discontinuation is associated with the following risks: (1)
withdrawal/discontinuation symptoms or rebound syndromes related to cholinergic,
histaminergic, and serotonergic activity; (2) supersensitivity syndromes (e.g., withdrawal
dyskinesia, supersensitivity psychosis); and (3) exacerbation/re-emergence of symptoms
secondary to diminished response with newly introduced antipsychotic. On the other hand,
gradual antipsychotic discontinuation is associated with the risk of worsening/emergent side
effects. This said, all of the studies, including one meta-analysis, report no differences
in efficacy and safety between immediate and gradual discontinuation strategies in
antipsychotic switching. However, it should be also noted that all of the studies were
conducted under an open-label design or a single-blind design.
To address the gap in knowledge specific to clozapine, the investigators conducted a pilot,
8-week, double-blind, randomized controlled trial examining immediate vs. gradual
antipsychotic discontinuation in patients with schizophrenia undergoing a switch to
clozapine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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