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Adherence therapy

Phase 1

Schizophrenia | Unknown | Psychiatry |Castle Biosciences, Inc.|Last Updated: Feb 19, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment134
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01780116Effectiveness of Adherence Therapy for SchizophreniaPHASE1 COMPLETED 134May 1, 2013Feb 1, 2016Feb 19, 20162 Hong Kong
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Study Endpoints
Primary Endpoints
re-hospitalization rate
12 months after completion of intervention

rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken

Secondary Endpoints
level of medication adherence
12 months follow-up
mental status
12 months follow-up
insight into treatment
12 months follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
Medicaiton adherence therapyEXPERIMENTALAdherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases: 1. Engaging patients: assessing needs and concerns in medication adherence; 2. Reviewing strengths and barriers and developing coping strategies; and 3. Rationalizing beliefs and concerns and preventing relapse.
Routine community careNO_INTERVENTIONRoutine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field
Interventions
NameTypeDescription
Adherence therapyBEHAVIORALSystematic and highly structured medication adherence program using the motivational interviewing (MI) technique that focuses on six principles: expressing empathy, developing discrepancy between client's beliefs and evidence, supporting self-efficacy, avoiding argumentation, and rolling with resistance to behavioral change. MI is often able (with in-depth behavioral analysis) to focus on particular consequences of problem behavior, such as medication non-adherence, that have an obvious impact on patients.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria of the patients include those who: * are Hong Kong Chinese residents; * have a primary diagnosis of schizophrenia or its subtypes such as schizophreniform and schizoaffective disorders not more than 3 years; * have been prescribed oral antipsychotics for at least 1 month; * are a...

Countries:Hong Kong
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