Overview

Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)

Status:
Completed
Trial end date:
2020-07-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Western Reserve University
Collaborators:
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Treatments:
Haloperidol
Haloperidol decanoate
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