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CUtLASS TRIAL. Ron Beasley, PharmD Candidate Preceptor: Soheyla M ahdavian, PharmD. CUtLASS TRIAL. C ost U tility of t he L atest A ntipsychotic Drugs in S chizophrenia S tudy Tested at Fourteen community psychiatric services in the English National Health Service .

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cutlass trial


Ron Beasley, PharmD Candidate

Preceptor: SoheylaMahdavian, PharmD

cutlass trial1
  • Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study
  • Tested at Fourteen community psychiatric services in the English National Health Service.
  • Published in Archives of General Psychiatry in 2006
  • To test the hypothesis that in people with schizophrenia SGAs improve quality of life across 1 year compared with FGAs.
  • Multisite, randomized controlled trial of antipsychotic drug classes, with
  • Blind assessments at 12, 26, and 56 weeks using intention-to-treat analysis.
  • 227 people aged 18 to 65 years with DSM-IV schizophrenia and related disorders assessed for medication review because of inadequate response or adverse effects.
  • Following randomization, the referring psychiatrists would choose a medication from the assigned class to administer for up to 1 year's duration.
methods cont
Methods Cont.
  • The FGAs were
    • Chlorpromazine hydrochloride,
    • Flupenthixol *
    • Haloperidol
    • Loxapine
    • Methotrimeprazine*
    • Sulpiride*
    • Trifluoperazine hydrochloride
    • Zuclopenthixol*
    • Depot Preperations
      • Fluphenazinedecanoate,
      • Flupentixoldecanoate*
      • Haloperidol decanoate
      • Pipothiazinepalmitate *
      • Zuclopenthixoldecanoate *

*Not in the USA

methods cont1
Methods Cont.
  • SGAs were
    • Risperidone
    • Olanzapine
    • Amisulpride*
    • Zotepine*
    • Quetiapine

*Not in the USA




Substance misuse or a medical disorder considered clinically to be the major cause of positive psychotic symptoms and a history of neuroleptic malignant syndrome.

  • DSM-IV schizophrenia, schizoaffective disorder, or delusional disorder
  • Age 18 to 65 years
  • At least 1 month since the first onset of positive psychotic symptoms
  • Psychiatrist electing to change the current FGA or SGA treatment because of inadequate clinical response or in- tolerance.
outcome measurements
Outcome Measurements
  • The primary outcome measure was total score on the Quality of Life Scale (QLS), assessed blindly at baseline and at Weeks 12, 26, and 52 of the study.
  • Secondary outcome measures included:
    • Positive and Negative Syndrome Scale (PANSS)
    • Calgary Depression Scale
    • Various scales looking at adverse medication effects
    • Participant satisfaction
  • SGAs did not show superiority in improvement in the QLS. In fact, there was a numerical trend toward greater improvement with the FGA cohort.
  • Healthcare costs were similar in both groups with psychiatric inpatient hospitalization responsible for the majority of the expense.
  • Although SGAs were more expensive than FGAs, total antipsychotic medication cost was a relatively small proportion of total expenses (2.1% and 3.8% for FGAs and SGAs, respectively).
results cont
Results cont.
  • There was no measurable difference between the 2 cohorts in:
    • Positive or negative symptoms
    • Depressive symptoms
    • Adverse effects
critique pros
Critique (Pros)
  • It is consistent with several other recent studies showing minimal to no clinical or cost-savings advantage of SGAs over FGAs
  • It is a practical, blinded, well-designed trial that contains discussion about why the original premise (SGA superior to FGA) could not be proven
  • Effect size, sample size, statistical power, utility of the QLSall were assed for bias
critique cons
Critique (Cons)
  • This study fails to answer key questions:
    • Are second-generation antipsychotic medications overrated?
    • Do SGA’s really provide patients with an advantage over first-generation antipsychotics?
  • Limited sample size and statistical power
  • Psychiatrists may have been less ready to change from SGAs compared with FGAs in treating the patients skewing results.
  • 1. Voruganti L, Cortese L, Oyewumi L, Cernovsky Z, Awad A. Comparative evalu- ation of conventional and novel antipsychotic drugs with reference to their sub- jective tolerability, side-effect profile and impact on quality of life. Schizophr Res. 2000;43:135-145.
  • 2. National Collaborating Centre for Mental Health. Guidance on the Use of Newer (Atypical) Antipsychotic Drugs for the Treatment of Schizophrenia. London, En- gland: National Institute for Clinical Excellence; 2002.
  • 3. Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second- generation antipsychotics. Arch Gen Psychiatry. 2003;60:553-564.