Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up
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.
      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 at 3 years of follow-up.
    

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: 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) and
      the Scale for the Assessment of Negative symptoms (SANS) 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 to assess side effects. 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. The same trained psychiatrist (BC-F) completed all clinical
      assessments.
    

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