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1. JOURNAL READING
PSYCHIATRY
RSKD MALUKU PROVINCE
FACULTY OF MEDICINE
PAPUA UNIVERSITY
Supervisor : dr. Sherly Yacobus, Sp. KJ
Compiled by : Ester Novella Duwit

2. PROFILE JOURNAL
Tittle
Researcer name
Publisher
FACULTY OF MEDICINE
PAPUA UNIVERSITY

3. Abstract
FACULTY OF MEDICINE
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4. Background
 Preventing relapse and hospitalization in schizophrenia is a major public
health challenge.
 Antipsychotic medications reduce relapse risk (NNT = 3) and lower overall
mortality rates.
 Long-acting injectable antipsychotics (LAIs) are more effective than oral
medications.
Adherence Issues
 Relapses have serious consequences, especially in early stages of illness.
 Second psychotic episodes tend to respond less well to treatment than the
first.
 Studies show that 35.7% of patients discontinue medication within 30 days,
and 54.3% within 60 days after first hospitalization.
 LAIs can improve adherence, but physicians often consider LAIs only after
repeated relapses.
INTRODUCTION
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5. Limitations of Previous Research
 Some RCTs and observational studies show LAIs are
superior; others do not.
 RCT participants tend to be more adherent than general
patient populations.
 Large simple trials are needed to provide more
representative and real-world data.
INTRODUCTION
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6. Study Objective
 To assess time to first psychiatric hospitalization between
LAI aripiprazole monohydrate and antipsychotic
treatment as usual over a 2-year period.
 Focus on early-phase schizophrenia patients before a
pattern of repeated hospitalizations develops.
OBJECTIVE
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7. Study Design
 PRELAPSE Study : Investigator-initiated, multicenter,
cluster-randomized clinical trial.
 Clinics were divided into two groups: LAI treatment
(AOM) vs. usual antipsychotic treatment (CC).
 Participants only consented to the treatment assigned to
their clinic—not to individual randomization.
 Enrollment: Dec 2014 – Final Assessment: Mar 2019.
 Participants gave written informed consent before any
procedures.
METHODS
FACULTY OF MEDICINE
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8. Location :
 Clinics eligible if they had:
 Early-phase schizophrenia patients,
 LAI treatment capacity,
 Willingness to be randomized.
 Clinics paired by characteristics (academic/community).
 41 clinics randomized; 39 remained active across U.S.
state:
 19 clinics (AOM group)
 20 clinics (CC group)
METHODS
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9. Statistical Analysis, consist of :
 Primary: Cox regression with robust sandwich estimator
(accounts for clustering).
 Sensitivity: Discrete-time mixed-effects survival model.
 Secondary:
 Poisson regression: Hospitalization rates,
 Linear mixed models: Changes in QLS, BPRS.
 Software: SAS v9.4
 Visualization: Kaplan-Meier survival curve.
STATISTICAL ANALYSES
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10. Inclusion Criteria:
 DSM-5 schizophrenia diagnosis via SCID-5,
 <5 years antipsychotic use,
 Aged 18–35,
 Capable of informed consent.
Exclusion Criteria:
 Other primary psychiatric diagnosis,
 Pregnant/lactating,
 Unstable medical condition,
 Prior clozapine use,
 Aripiprazole intolerance (AOM sites only)
Participant Eligibility
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PAPUA UNIVERSITY

11. Intervention Protocol
 AOM Group: Free AOM + standard services.
 AOM prescribed per FDA guidelines (oral lead-in, proper
injection intervals).
 Switch to alternate treatment allowed if needed.
 CC Group: Standard treatment as determined by clinic
(LAI optional).
INTERVENTION
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12. Determination of Primary Outcome
 Data source: Hospitalization, ER, and Crisis (HEC) forms,
completed every 2 months.
 Recorded 8 inpatient event types, including:
 Psychiatric hospitalization, psychiatric ER visits, detox stays, and crisis
stabilization.
 Events cross-checked with Serious Adverse Event (SAE)
reports.
Primary outcome defined as:
 Psychiatric hospitalizations,
 Overnight stays in crisis units or psychiatric ERs,
 Select detox or transitional housing stays with inpatient-like context.
INTERVENTION
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13. Event Review & Classification
 384 total events:
 184 classified as psychiatric hospitalization by chair + 1
reviewer.
 200 events reviewed by an independent review committee.
 Committee: 3 senior psychiatrists + 1 biostatistician
( Joanne Severe, MS).
 Events were anonymized and randomly ordered.
INTERVENTION
FACULTY OF MEDICINE
PAPUA UNIVERSITY

14. Primary Classification Categories
 P = Psychotic symptoms present (main cause of
admission),
 O = Non-psychotic psychiatric cause (e.g., depression,
anxiety, SI/SA),
 U = Undetermined (not enough info or unclear),
 D = Detox/Rehab (excluded from primary outcome),
 NIV = Not an inpatient visit.
FACULTY OF MEDICINE
PAPUA UNIVERSITY

15. Additional Subcategories
 Commitment-related: Suicidal/homicidal ideation or
attempt,
 Internal mood: Depression, anxiety, anger,
 Overt/social behavior: Aggression, social issues,
 None: No clear secondary reason noted.
FACULTY OF MEDICINE
PAPUA UNIVERSITY

16. Primary Outcome
 Time to First Psychiatric Hospitalization
 Tracked via phone interviews (every 2 months) and resource use
forms (every 4 months).
 Verified via records; adjudicated by blinded committee.
 Included: Overnight stays in crisis or psychiatric EDs.
 Excluded: Substance detox-only admissions.
FACULTY OF MEDICINE
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17. Secondary Outcomes
 Assessed at baseline, 12 months, 24 months:
 BPRS, CGI, C-SSRS, QLS, SCID-5, RBANS.
 Adverse events tracked via clinical visits (every 6
months).
 Aim: Limit extra contact beyond normal care.
FACULTY OF MEDICINE
PAPUA UNIVERSITY

23. eFigure 1. Heinrichs Carpenter Quality of Life (QLS) Scale Total Score
Over Time

24. eFigure 2. Brief Psychiatric Rating Scale (BPRS) Score Total Score Over
Time

25. eFigure 3. Brief Psychiatric Rating Scale (BPRS) Score Thought
Disturbance Factor Score Over Time

26. eFigure Summary
 eFigure 1 – QLS Total Score:
 Quality of life stable; no significant group difference.
 eFigure 2 – BPRS Total Score:
 General symptom improvement over time; no group difference.
 eFigure 3 – BPRS Thought Disturbance:
 Stable over time; no significant difference between AOM and CC.
RESULT
FACULTY OF MEDICINE
PAPUA UNIVERSITY

27. The use of LAIs like aripiprazole monohydrate significantly
delays first hospitalization in early-phase schizophrenia.
These findings suggest clinicians should more broadly
consider LAI treatment for early-phase patients.
Conclusion
 LAI use in early-phase schizophrenia led to a clinically
meaningful 44% reduction in first hospitalization risk.
 NNT = 7 confirms strong preventive potential of LAIs in
this population.
CONCLUSION
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PAPUA UNIVERSITY

28. CONCLUSION
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29. Limitations
 Baseline characteristics between groups were similar,
but:
 Cluster randomization could allow for selection effects.
 High LAI usage in CC group may underestimate AOM’s
benefits.
 Study only tested one LAI formulation (AOM).
 Results likely generalizable due to mix of academic and
community sites.
 Site training was key—should be implemented more
broadly.
LIMITATIONS
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PAPUA UNIVERSITY

30. THANK YOU 