Schizophrenia Clinical Trial
Official title:
Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics
Background: The aims of this study were to explore the relationship between early reduction
in psychotic symptoms and the ultimate response in patients with schizophrenia treated by
atypical antipsychotics, and to determine the best time to switch or maitain the regimen. PI
also explore the possible predictors for the clinical response.
Methods: One hundred eleven inpatients with acutely exacerbated schizophrenia were randomized
to give optimal therapy of olanzapine, risperidone, and paliperidone in one-week run-in
period and 12 weeks' intervention. All participants were assessed using Positive and Negative
Syndrome Scale (PANSS). Early Response, defined as reduction of 25% in PANSS score, was
examined at weeks 1, 2, 3, 4 and 8, and these ratings were used to predict ultimate response
(25% PANSS reduction) at week 12. PI hypothesized that early treatment response at Week 1 or
2 could predict Week 12's treatment outcome.
Study Design: This study recruited hospitalized adult patients who had a relapse of
schizophrenia. All participants had received antipsychotic treatment for a period of time
previously. They have to meet the diagnostic criteria for schizophrenia according to the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). One hundred
and twenty adult inpatients were recruited and were randomly assigned to receive olanzapine
(n=60), risperidone (n=30) and paliperidone (n=30) in an allocation ratio of 2:1:1. The
participants were allowed to change the dosage of antipsychotics and their hospitalization
status according to the judgement of in-charged physicians during the study period.
The study was approved by the Institutional Review Board and written informed consents were
obtained either directly from the patients or from their legal guardians after the study had
been explained. The inclusion criteria for this study were: (1) age 18 to 65 years, (2) no
major systemic illnesses based on physical examinations and laboratory test results, and (3)
baseline PANSS total scoreā§60. The exclusion criteria were as follows: (1) participants not
taking any antipsychotics in the previous one month, (2) participants were pregnant and
lactating women, and (3) history of clozapine treatment in the previous 3 months, and (4)
patients receiving long-acting antipsychotic injections in the preceding 6 months of
enrollment.
This study was conducted by a 12-week, open-label and naturalistic randomized design. A
tri-therapy (olanzapine, risperidone, and paliperidone) completely randomized design was
adopted for this study, which involved three homogeneous groups of patients with a run-in
period of 3 months. The patients were required to have discontinued all prior use of
antipsychotics for a period of at least 7 days before their entry into the study. During
wash-out period, administration of either oral benzodiazpines, hypnotics or injection of
lorazepam to control anxiety, insomnia and aggression were allowed. After the wash-out
period, the patients received treatment with an atypical antipsychotic drug, olanzapine,
risperidone or paliperidone for 3 months.
The Positive and Negative Syndrome Scale (PANSS) rating scale was used to evaluate the
changes of psychiatric symptoms in each time point. The subject patients were interviewed for
the PANSS by senior psychiatrists. The raters in the present study had worked mainly on
inpatient treatment of severe schizophrenic patients, and were well acquainted with symptoms
of schizophrenia. Prior to the present study, all participating psychiatrists had received
adequate training through the manual and they had had clinical experience in the PANSS rating
before the study. At each time point if the scores of PANSS showed the patient's symptoms had
worsened, the dosage would be adjusted based on the clinical judgment of in-charged senior
psychiatrist. However, if the scores of PANSS were improved, the dosage was maintained. The
recommended dose for the three groups were as follows: 10 to 20 mg daily for olanzapine, 4 to
6 mg daily for risperidone, and 6 to 12 mg daily for paliperidone. Throughout the study
period, the paticipants were allowed to continuously use some concomitant medication,
including lorazepam (up to 6 mg/day) for insomnia or agitation and biperiden (up to 6 mg/day)
for treatment of extrapyramidal side effects. No other psychotropic agents were administered
during the 12-week study.
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