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document
An Exploratory , Open-Label , Randomized Trial Comparing Risperidone Long-Acting Injectable with Oral Antipsychotic Medication in the Treatment of Early Psychosis . Few studies have examined effectiveness and tolerability of risperidone long-acting injections ( RLAI ) in the early phase of a schizophrenia spectrum ( SS ) disorder using a randomized controlled trial ( RCT ) design . Eighty-five patients in early phase of an SS disorder were randomized to receive either oral second-generation antipsychotics ( SGAs ; n=41 ) or RLAI ( n=44 ) over two years . Analyses were conducted on eligible participants ( n=77 ) for the stabilization ( maximum 18 weeks ) and maintenance phases ( up to Week 104 ) on primary outcome measures of time to stabilization and relapse , change in symptoms and safety , and comparisons made across the two groups . Both groups showed improvement on Positive and Negative Syndrome Scale ( PANSS ) scores and Clinical Global Impression-Severity ( CGI-S ) scores . There were no time X group interactions on any of the primary outcome measures . Post hoc examination revealed that the RLAI group showed greater change on CGI-S and PANSS negative symptom scores during the stabilization phase , while the oral group reached the same level of improvement during the maintenance phase . The current exploratory study suggests that-within an RCT design-RLAI and oral SGAs are equally effective and have similar safety profiles in patients in the early phase of SS disorders . Thus , RLAI offers no advantage to patients in early phase of SS disorders , but is likely to be effective and safe for those who may have problems with adherence and may either choose to take it or be prescribed under conditions of external control such as community treatment orders .
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Intervention_Pharmacological
Risperidone Long-Acting Injectable
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Intervention_Pharmacological
Oral Antipsychotic Medication
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Intervention_Pharmacological
risperidone long-acting injections ( RLAI )
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Intervention_Pharmacological
oral second-generation antipsychotics ( SGAs
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Intervention_Pharmacological
RLAI
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Outcome_Other
time to stabilization
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Outcome_Physical
relapse
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Outcome_Other
change in symptoms and safety
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Outcome_Other
comparisons
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Outcome_Other
Positive and Negative Syndrome Scale ( PANSS ) scores
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Outcome_Other
Clinical Global Impression-Severity ( CGI-S ) scores
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Outcome_Physical
CGI-S
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Outcome_Physical
PANSS negative symptom scores
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Outcome_Physical
effective
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Outcome_Other
similar safety profiles
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Outcome_Mental
effective
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Outcome_Other
safe
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Participant_Condition
Early Psychosis .
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Participant_Condition
schizophrenia spectrum ( SS ) disorder
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Participant_Sample-size
Eighty-five patients
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Participant_Condition
SS disorder
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Participant_Sample-size
n=77