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CAFE TRIAL

CAFE TRIAL. Ron Beasley, PharmD Candidate Preceptor: Soheyla M ahdavian, PharmD. CAFE TRIAL. C omparison of A typicals in F irst E pisode of p sychosis

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CAFE TRIAL

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  1. CAFE TRIAL Ron Beasley, PharmD Candidate Preceptor: SoheylaMahdavian, PharmD

  2. CAFE TRIAL • Comparison of Atypicals in First Episode of psychosis • The study, Comparison of Atypicals for First-Episode Psychosis (CAFE), involved 26 centers in the U.S. and Canada, and it recruited patients who were experiencing their first psychotic episode. • CAFE was funded by AstraZeneca, the maker of Seroquel. • Published in the American Journal of Psychiatry in 2007

  3. Objectives • To determine whether there were any advantages among the atypical antipsychotic agents for first-episode • This was a 52-week randomized, double-blind, flexible-dose, multicenter study

  4. Methods • Compared quetiapine (Seroquel®), risperidone (Risperdal®), and olanzapine (Zyprexa®) in these patients. • There were 134 patients in the quetiapine (Seroquel®) group and 133 each in the olanzapine and risperidone(Risperdal®) groups.

  5. Criteria Inclusion Exclusion The patients could not have had a previous psychotic episode from which they recovered; nor could they have a lifetime history of more than 16 weeks of antipsychotic treatment. • 16 to 40 years old, had a diagnosis of first-episode schizophrenia, and had psychotic symptoms for one month to five years, • Scores greater than 4 on the Positive and Negative Symptoms Score (PANSS) psychosis subscale.

  6. Positive and Negative Syndrome Scale • The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. • 1-Absent • 2-Minimal • 3-Mild • 4-Moderate • 5-Moderate severe • 6-Severe • 7-Extreme

  7. Positive Scale • 7 Items, (minimum score = 7, maximum score = 49) • Delusions • Conceptual disorganization • Hallucinations • Hyperactivity • Grandiosity • Suspiciousness/persecution • Hostility

  8. Negative Scale • 7 Items, (minimum score = 7, maximum score = 49) • Blunted Affect • Emotional withdrawal • Poor rapport • Passive/apathetic • Difficulty in abstract thinking • Lack of spontaneity and flow of conversation • Stereotyped thinking

  9. General Psychopathology Scale • 16 Items, (minimum score = 16, maximum score = 112) • Somatic concern • Anxiety • Guilt feelings • Tension • Mannerisms and posturing • Depression • Motor retardation • Uncooperativeness • Unusual thought content • Disorientation • Poor attention • Lack of judgment and insight • Disturbance of volition • Poor impulse control • Preoccupation • Active social avoidance

  10. PANSS Total Score • Minimum = 30 • Maximum = 210 • The PANSS is a relatively brief interview, requiring 45 to 50 minutes to administer.

  11. Primary Outcome Measurment • Discontinuation of treatment could be due to an • Inadequate effect • Adverse effects • Patient decision • Failure to keep appointments, • Desire to stop medication for personal reasons • Patient-specific reasons for stopping treatment. • The average doses were 11.7 mg for olanzapine, 506 mg for quetiapine, and 2.4 mg for risperidone.


  12. Results • There was no difference among the drugs in terms of the all-cause discontinuation rate • After one year of treatment, all three of the medications had a pretty high rate of discontinuation, about 70% in all of them. • There was no difference in subcategories of reasons for discontinuation, whether it was patient decision or inadequate effect • The analysis of the improvement of positive symptoms showed that patients on olanzapine improved more than those on quetiapine

  13. Results Cont. • Of those treated with olanzapine, 80% gained 7% or more over their baseline weight compared with 57.6% of those receiving risperidone and 50% of those receiving quetiapine.

  14. Critique Pros Cons They allowed patients who had some prior antipsychotic treatment to participate CAFE was funded by AstraZeneca, the maker of Seroquel. • The three testing groups were not significantly different giving more accurate results • They tested for multiple secondary outcomes making this trial more clinically useful

  15. References • 1. Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S: Phar- macological long-term treatment strategies in first episode schizophrenia: study design and preliminary results of an on- going RCT within the German Research Network on Schizo- phrenia. Eur Arch Psychiatry Clin Neurosci 2004; 254:129–140 • 2. Good KP, Kiss I, Buiteman C, Woodley H, Rui Q, Whitehorn D, Kopala L: Improvement in cognitive functioning in patients with first-episode psychosis during treatment with quetiapine: an interim analysis. Br J Psychiatry 2002; 43(suppl):S45–S49 • 3. MallaAK, Norman RM, Scholten DJ, Zirul S, Kotteda V: A com- parison of long-term outcome in first-episode schizophrenia following treatment with risperidone or a typical antipsychotic. J Clin Psychiatry 2001; 62:179–184

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