Schizophrenia Clinical Trial
Official title:
Phase IV Study of the Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II)
The selection of antipsychotic in early stages of the illness is mainly determined by its clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a homogeneous group and clinical effects and profile of side effects differ between SGAs. Differences among antipsychotics in terms of effectiveness have turned out to be a topic of increasing research interest, although comparisons between the different SGAs are scarce. In first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less evident seems to be the notion that some of the SGAs might be more effective (in terms of treatment discontinuation) than others. Most of the medium-term randomized studies have shown similar rates of all-cause treatment discontinuation in first episode patients treated with different SGAs. It may be concluded that more randomized controlled trails should be accomplished to determine the position of frequently used SGAs in clinical practice. The investigators undertook this study with the major objective of comparing the clinical effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the acute treatment of first-episode non-affective psychosis individuals.
Study setting and financial support: data for the present investigation were obtained from
an ongoing epidemiological and three-year longitudinal intervention program of first-episode
psychosis (PAFIP) conducted at the outpatient clinic and the inpatient unit at the
University Hospital Marqués de Valdecilla, Spain. Conforming to international standards for
research ethics, this program was approved by the local institutional review board. Patients
meeting inclusion criteria and their families provided written informed consent to be
included in the PAFIP. The Mental Health Services of Cantabria provided funding for
implementing the program. None pharmaceutical company supplied any financial support to it.
Study design: this is a prospective, randomized, flexible-dose, open-label study. At study
intake, all patients but eight were antipsychotic naïve. Dose ranges were 5-20 mg /day
Aripiprazole, 40-160 mg/day Ziprasidone and 100-600 mg/day Quetiapine. Rapid titration
schedule (5-day), until optimal dose was reached, was as a rule used unless severe side
effects occur. At the treating physician´s discretion, the dose and type of antipsychotic
medication could be changed based on clinical efficacy and the profile of side effects
during the follow-up period. Antimuscarinic medication, Lormetazepam and Clonazepam were
permitted for clinical reasons. No antimuscarinic agents were administered prophylactically.
Antidepressants (Sertraline) and mood stabilizers (lithium) were permitted if clinically
needed.
The severity scale of the Clinical Global Impression (CGI) scale, the Brief Psychiatric
Rating Scale (BPRS), the Scale for the Assessment of Positive symptoms (SAPS), the Scale for
the Assessment of Negative symptoms (SANS), the Calgary Depression Scale for Schizophrenia
(CDSS) and the Young Mania Rating Scale (YMRS) were used to evaluate symptomatology. To
assess general adverse event experiences the Scale of the Udvalg for Kliniske Undersogelser
(UKU), the Simpson-Angus Rating Scale (SARS) and the Barnes Akathisia Scale (BAS) were used.
The same trained psychiatrist (BC-F) completed all clinical assessments.
The adverse events were evaluated using the UKU Side effect rating scale. Those
treatment-emergent adverse events that occurred at a rate of at least 10% in either
treatment group are considered. Treatment-emergent akathisia (BAS) and extrapyramidal
symptoms (SARS) were assessed by both baseline-to-end changes and newly emergent categorical
changes.
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