Phase 3
Completed N=19
Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
Schizophrenia · Medication Nonadherence · Schizo Affective Disorder
Source: ClinicalTrials.gov NCT04327843 ↗
Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Oct 2021
Primary outcomePrimary: Tablets Routine Questionnaire (TRQ) — -57; -23 percentage of change in adherence
◆ Published Evidence
Emerging
4citations · ~1 / year
An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania.
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.
Linked Publications
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An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tablets Routine Questionnaire (TRQ) |
-57; -23 | — |
| PRIMARY Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: |
18 | — |
| SECONDARY Drug Attitude Inventory (DAI) |
7.89; 9.83 | 0.001 sig |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
27.00; 25.06 | 0.43 |
| SECONDARY Clinical Global Impressions (CGI) |
2.88; 2.24 | 0.07 |
| SECONDARY Social and Occupational Functioning Scale (SOFAS) |
62.17; 68.39 | 0.10 |
| SECONDARY Body Mass Index |
22.79; 22.92 | 0.75 |
| SECONDARY ESRS-A Parkinsonism |
0.06; 0.06 | 1.00 |
| SECONDARY ESRS-A Dystonia |
0.00; 0.00 | — |
| SECONDARY ESRS-A Dyskinesia |
0.17; 0.11 | 0.75 |
| SECONDARY ESRS-A Akathisia |
0.28; 0.00 | 0.14 |
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
Data sourced from ClinicalTrials.gov (NCT04327843) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.