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B R I T I S H J O U R N A L O F P S YC H I AT RY ( 2 0 0 7 ) , 1 9 1 ( s u p p l . 5 1 ) , s 9 6 ^ s 1 0 1 . d o i : 1 0 . 11 9 2 / b j p . 1 9 1 . 5 1 . s 9 6 medication in the previous 3 months; (f)change in dosage of any antidepressant within 6 weeks, stimulant medication with-in 4 weeks, or mood stabiliser within 4 COPS are based on sub-threshold levelsof positive symptoms and operationally de-fine three prodromal The prodromal phase of schizophrenic dis- orders has been recognised since the 19th century (Bleuler, 1911) and the possibility detail elsewhere (Woods et al, 2001; Miller to investigate methods to prevent progres- et al, 2003a). Individuals were assessed to dromal phase to frank psychosis (Falloon, using the Structured Interview for Prodro- mal Syndromes (SIPS; Miller et al, 1999).
Reliability of the COPS diagnosis of pos- have focused on the acute treatment effects on current symptoms (Woods et al, 2003).
using the SIPS (Miller et al, 2002, 2003a), psychotic medication with limited liability atic (Miller et al, 2003b), functionally im- for weight gain (Marder et al, 2003), whose paired (Miller et al, 2003b), cognitively antipsychotics in that it is a partial agonist treatment-seeking (Preda et al, 2002).
rather than a full antagonist at dopamine overall goal of the present pilot study was Participants were enrolled between October the efficacy and safety of aripiprazole in trial is registered with study at one site for 8 weeks, followed by monthly follow-up visits to 52 weeks.
Findings from the extension phase will be assent with consent from a parent or guar-dian. Participants were included if they were treatment-seeking out-patients of 13– During the 1–2 weeks prior to beginning 40 years of age who met diagnostic criteria for a possible prodromal syndrome. People eligibility and neuropsychological examina- reasons: (a) past or current DSM–IV criter- ia (American Psychiatric Association, 1994) for any lifetime psychotic disorder; (b) they were judged clinically to have a psychiatric ule. Initial doses were 5 mg/day aripipra- disorder (e.g. mania, depression, attention- zole; after 1 week, the dose was scheduled deficit hyperactivity disorder) which could for increase to 10 mg/day and after 2 weeks to 15 mg/day, unless adverse effects dic- tated a slower titration schedule. After the as sequelae to drug or alcohol use; (d) alco- there are a dearth of age-specific normative data (our sample with test–retest data has a a single daily dose unless there was a reason mean age of 15.5 years, s.d.¼1.3), baseline Spreen & Benton, 1969) test of phonemic logical impairment similar to that observed used to calculate the percentage adherence managed initially by switching the timing ministration of the Simpson–Angus Scale by Spreen & Strauss (1998) and substan- of the daily dose to bedtime or by dividing (SAS; Simpson & Angus, 1970), the Barnes tially better Trail-Making Part A and Part B performances were reported for a healthy by switching the timing of the daily dose treat insomnia or agitation. Lorazepam or adverse events (Systematic Assessment For (EPS). Participants continued doses of anti- cific inquiry method; Levine & Schooler, depressant, mood stabiliser, or stimulant 1986), vital signs and weight. Treatment- feeling medication was no longer needed.
were not permitted to begin or increase do- cation and left the study primarily because sage of these medications after consent.
of sedation after the first 10 mg dose, after assessed at baseline and weekly thereafter.
having concluded that 5 mg was ineffective ventions with supportive and psychoeduca- For the present report, the time frame wasthe first 8 weeks after beginning study Prescribed mean (s.d.) aripiprazole doses at weeks 1, 2, 3, 4, 5, 6, 7 and 8 were 5 (0), 9(2), 11 (5), 11 (7), 11 (6), 13 (6), 14 (8), and The primary efficacy measure for the analy- measure was the SOPS total score. Analyses sis of acute treatment was change over time in the total score of the Scale of Prodromal principle. All participants were included in Symptoms (SOPS; Miller et al, 1999), a 19- item scale with items scored 0–6. The inter- 30 mg/day (n¼1). Reported mean (s.d.) per- rater reliability has been excellent (Miller et likelihood-based repeated measures linear al, 2003a). Factor analysis supports the val- zole doses was 94 (13), 92 (22), 98 (4), 96 (8), 97 (7), 95 (10), 98 (5), and 94 (9) at al, 2004b). Treatment response was defined scores, using baseline scores as a covariate.
weeks 1, 2, 3, 4, 5, 6, 7 and 8 respectively.
For other measures we used t-test end-point Schizophrenia (CDSS; Addington et al,1990), the Young Mania Rating Scale (YMRS; Young et al, 1978), the Beck Anxi- A total of 15 participants were enrolled.
ety Inventory (BAI; Beck et al, 1988), the Demographic and treatment characteristics at baseline are shown in Table 1. All were and none also qualified for either of the syndromes. All but two had never received cluded tests of attention and working mem- antipsychotic medication prior to partici- pating. One participantt had received anti- (CPT; Cornblatt et al, 1988), identical pairs psychotic for 5 weeks 5 years earlier, and version, letter number sequencing, N-back, Trails A and B; Stroop Color Word Test for before baseline, both for indications other than psychosis. Scores for severity of illness at baseline are shown in Table 2. Although dose titration and prescribing anticholiner- aripiprazole into the extension phase.
gic medication (2), slowing dose titration and prescribing benzodiazepine (2) and pre- then adding benzodiazepine (1). In the con- working memory at the significant or trend text of these management efforts, all parti- three participants (20%) and anticholiner- gic medication in 5 participants (33%).
number correct) but worsened on one other akathisia remitted by the final evaluation as a group on a test of executive function- in six participants. Mean BAS total scores In the mixed-effects model, the effect of end-point evaluation (Table 5). Four parti- time for the SOPS total score change from Scores on the remaining 15 tests of atten- baseline was statistically significant (F tion, working memory, executive function- for akathisia at the 8-week evaluation.
SOPS total score was statistically signifi- was observed for blood pressure (Table 5).
cant at each time point (Fig. 1). The LOCF Pulse increased 6 beats per minute on aver- analyses revealed that improvement on the age. There were no significant differences SOPS was statistically significant at end- point for each of the positive, negative, One participant discontinued aripiprazole because of adverse events (sedation after 8 days). As determined by the SAFTEE, there were few adverse events of more than mild severity (Table 4). Complaints of adverse and BAI scales, as well as significant func- The principal finding of the present study for only 8 days, at the final evaluation an was that those meeting criteria for a schizo- criteria (73%) at week 2 (n¼1), 3 (n¼2), 4 or greater severity was present in only one (n¼1), 6 (n¼4), 7 (n¼1) and 8 (n¼2).
strated by increases from baseline on the ever, are the small sample size and the use course elected not to continue aripiprazole of an uncontrolled, open-label design.
pression measures, was also more robust in the open-label study of aripiprazole than compared favourably with our previousexperience with olanzapine. Participants whereas the aripiprazole mean weight gain in this study was 1.2 kg (Table 5) despitebeing exposed to drug for a higher propor-tion of the 8 weeks. This degree of weight prodromal for schizophrenia. Our findings result of placebo effects or simply the pas- can be compared with those from the acute previous short-term studies of aripiprazole but again one must allow for the different study designs. Participants with established problematic with aripiprazole than it had schizophrenia improved less from baseline rates of benztropine prescription. However, expected two or three conversions without dose titration or benzodiazepine prescrip- whether this same effect of design occurs tion, was effective in managing this adverse effect, so that by the final evaluation the net effect of treatment on akathisia ratings was volunteering for a placebo-controlled study relatively high in this short-term analysis as measured by participant report at each slightly more severely ill at baseline in the visit. Adherence was similar to or higher ledge to focus on an acute pharmacological current sample according to the SOPS total than with olanzapine in our masked study, score, although GAF scores at baseline and guidelines for initiation of aripiprazole inadolescents/children who weigh 50–70 kg(Findling et al, 2004).
Our current findings are relevant to discus- sions of the ethics of intervention research primarily focused on preventing the devel- certainly an important goal, ethical issues are raised because some participants will be false-positives who have no personal op-portunity to benefit if benefit is defined so- lely as prevention. The current data suggest that people carrying a risk of progression topsychosis can receive not only the possi-bility of a preventive benefit but also a treatment benefit ‘on average’ from inter- adherence (Woods et al, 2003). As for most studying prodromal v. chronic illness, or, vention. The prospect of treatment benefit studies, surreptitious non-adherence cannot our use of a counterbalanced alternate form on average is generally considered sufficient be excluded. Future studies should continue for the repeat verbal learning list, which to justify exposure to some treatment risk to assess adherence in this population.
in other illnesses. Thus the current data measurement of new verbal learning by fa- strengthen the argument that intervention little consistent effect of aripiprazole over miliarity with the word list carried over 8 weeks. Among the 20 results reported, a from the baseline testing (practice effect; few tests did show improvement, but others Hawkins & Wexler, 1999; Hawkins et al, showed a decline, with most suggesting lit- 2004c). In the previous study (Kern et al, people who meet prodrome criteria benefit 2006) aripiprazole-treated participants im- when prescribed aripiprazole, the present proved but not significantly on an executive results contribute to what is only the begin- appeared to be little consistency in direc- ning of the process of establishing a stand- to ours with WCST perseverative errors.
size in our study was small and we had no power to detect possible real effects; on control group, placebo or otherwise. Future placebo-controlled studies with more parti- pected on the basis of prior test exposure.
cipants are needed before recommendations can responsibly be made regarding routine aripiprazole in the current study. Although treatment. The present findings suggest that aripiprazole is a promising candidate for patients meeting prodrome criteria can be examinations before and 8 weeks after ran- are lower than those used in chronic schizo- dom assignment to aripiprazole or olanza- been used at too low a dose, especially in the first month (McGlashan et al, 2006).
fluency and trail-making tasks. Our failure In the present study we employed a recom- mended fixed dose titration by the end of measures could relate to our small sample the second week to 15 mg/day, the minimal or to our participants being less impaired consistently effective aripiprazole dose for and having less room to improve. Aripipra- zole-treated participants improved signifi- cantly in the previous study (Kern et al, 2006) on a verbal learning factor on which schedule. The 15 mg/day dose was also that loaded a test similar to our AVLT but with- out use of alternative forms. Our failure to schizophrenia (Brown et al, 2003). Initial


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