Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
Condition: Schizophrenia; Medication Nonadherence; Schizo Affective Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders
Intervention: Customized Adherence Enhancement; Haloperidol Decanoate
Intervention description: Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L.; Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study.
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nonadherence; Schizophrenia; Africa; Schizoaffective

Summary:

      The proposed, three phase project will refine and test a first-ever care approach in SSA that
      combines LAI with a behavioral program specifically intended to promote medication adherence
      in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements
      include: 1.) a manualized curriculum that targets specific barriers and facilitators to
      medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with
      CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing
      injection clinic health workers to deliver the adherence promotion program. Strengths include
      the highly generalizable methods and use of LAIs that are available in low-resource settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 and older

          -  Diagnosis of schizophrenia or schizoaffective disorder

          -  Known to have medication treatment adherence problems as identified by the TRQ (20% or
             more missed medications in past week or past month)

          -  Ability to be rated on psychiatric rating scales

          -  Willingness to take long-acting injectable medication

          -  Able to provide written, informed consent to study participation

        Exclusion Criteria:

          -  History of allergy or intolerance to haloperidol or haloperidol decanoate

          -  Individuals on long-acting injectable antipsychotic medication immediately prior to
             study enrollment

          -  Medical condition or illness, which in the opinion of the research psychiatrist, would
             interfere with the patient's ability to participate in the trial

          -  Physical dependence on substances (alcohol or illicit drugs) likely to lead to
             withdrawal reaction during the course of the study in the clinical opinion of the
             treated research psychiatrist

          -  Immediate risk of harm to self or others

          -  Female who is currently pregnant or breastfeeding