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

Schizophrenia Clinical Trial

— CAPACITY  

Official title:

Reducing the Burden of Chronic Psychotic Disorders in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327843
• Other study ID #: 1-17-19
• Secondary ID: R21MH114700
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: September 2021
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Nonadherence
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Tanzania	MUHAS	Dar Es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tablets Routine Questionnaire (TRQ)	The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 20-30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).	Change from Baseline to 6 month visit
Primary	Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections:	LAI injection adherence will be determined as a count of participants who received LAI injections at the appropriate time (within 7 days of scheduled time).	Baseline to 6 month visit
Secondary	Drug Attitude Inventory (DAI)	DAI-10 scoring ranges from -10 to +10 with a total score >0 indicating a positive attitude toward psychiatric medications and a total score of <0 indicating a negative attitude toward psychiatric medications.	Baseline to 6 month visit
Secondary	Brief Psychiatric Rating Scale (BPRS)	The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.	Baseline to 6 month visit
Secondary	Clinical Global Impressions (CGI)	The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.	Baseline to 6 month visit
Secondary	Social and Occupational Functioning Scale (SOFAS)	The SOFAS measures social and occupational functioning independent of the overall severity of the individual's psychological symptoms. The minimum score is 0 and the maximum score is 100. A higher rating implies a higher level of functioning.	Baseline to 6 month visit
Secondary	Body Mass Index	Body Mass Index kg/m^2 of participants	Baseline to Month 6(week 25)
Secondary	ESRS-A Parkinsonism	Extrapyramidal Symptoms Scale-Abbreviated version for Parkinsonism. It looks at drug-induced Parkinsonism which is made up of motor disturbances. Rigidity, tremor, reduced facial expression/speech, impaired gait/posture, postural instability, and bradykinesia. Each item is rated on a 4 point scale: 0=absent, 3=severe. The higher the value the more severe the Parkinsonism and worst outcomes.	Baseline to 6 months(25 weeks)
Secondary	ESRS-A Dystonia	Extrapyramidal Symptoms Scale-Abbreviated version for dystonia- drug-induced dystonia is a muscle disorder in which movements are jerky or twisting. Due to the 0.00 values at baseline and 25 weeks, unable to perform t-test and get a p value so no statistical analysis section is reported for this Outcome Measure. Each item is rated on a 4 point scale: 0=absent, 3=severe with the higher numbers indicating worse dystonia and worse outcomes.	Baseline to 6 months(25 weeks)
Secondary	ESRS-A Dyskinesia	Extrapyramidal Symptoms Scale-Abbreviated version for Dyskinesia- drug-induced dyskinesia which is repetitive and involuntary movements. Each item is rated on a 4 point scale: 0=absent, 3=severe and higher values indicate greater severity of dyskinesia and worse outcomes.	Baseline to 6 months(25 weeks)
Secondary	ESRS-A Akathisia	Extrapyramidal Symptoms Scale-Abbreviated version for akathisia- drug-induced akathisia consists of inner restlessness and urge to move. Items are measured on a 4 value scale: 0=absent, 3=severe, and higher values indicate more severe akathisia and worse outcomes.	Baseline to 6 months(25 weeks)