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

PHASE3CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

July 30, 2020

Study Completion Date

July 30, 2020

Conditions
SchizophreniaMedication NonadherenceSchizo Affective Disorder
Interventions
BEHAVIORAL

Customized Adherence Enhancement

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.

DRUG

Haloperidol Decanoate

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.

Trial Locations (1)

Unknown

MUHAS, Dar es Salaam

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Case Western Reserve University

OTHER

NCT04327843 - Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY) | Biotech Hunter | Biotech Hunter