Status:
COMPLETED
Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Patient Noncompliance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adher...
Eligibility Criteria
Inclusion
- Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
- Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
- Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).
- Ability to be rated on psychiatric rating scales.
- Willingness to take long-acting injectable medication.
- Currently receiving treatment at a Community Mental Health Clinic (CMHC) or another mental health treatment provider who is able to provide continuity of care during and after study participation.
- Able to provide written, informed consent to study participation.
- Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.
Exclusion
- Known resistance or intolerance to haloperidol or haloperidol decanoate.
- Medical contraindication to haloperidol or haloperidol decanoate.
- Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
- Prior or current treatment with clozapine.
- Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.
- Current substance dependence.
- High risk of harm to self or others.
- Female who is currently pregnant or breastfeeding.
- Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01152697
Start Date
June 1 2010
End Date
August 1 2012
Last Update
December 30 2014
Active Locations (1)
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1
University Hosptials
Cleveland, Ohio, United States, 44106