Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in the Treatment of First Episode Nonaffective Psychosis
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Aripiprazole; Quetiapine; Ziprasidone
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Abilify; Seroquel; Zeldox
Intervention MeSH terms: Aripiprazole; Quetiapine Fumarate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychosis; antipsychotic agents; treatment; effectiveness