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

NCT04327843 | Completed Phase 3 Results

• 2 other identifiers: 1-17-19R21MH114700
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Medication Nonadherence; Schizo Affective Disorder

Keywords

nonadherence; Schizophrenia; Africa; Schizoaffective

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Drug Attitude Inventory (DAI)

  Baseline to 6 month visit

• Brief Psychiatric Rating Scale (BPRS)

  Baseline to 6 month visit

• Clinical Global Impressions (CGI)

  Baseline to 6 month visit

• Social and Occupational Functioning Scale (SOFAS)

  Baseline to 6 month visit

• Body Mass Index

  Baseline to Month 6(week 25)

Study Arms (1)

CAE + LAI

EXPERIMENTAL

Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)

Behavioral: Customized Adherence Enhancement; Drug: Haloperidol Decanoate

Interventions

Customized Adherence Enhancement BEHAVIORAL

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.

Also known as: CAE

CAE + LAI

Haloperidol Decanoate DRUG

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.

Also known as: Haldol Decanoate

CAE + LAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

MUHAS

Dar es Salaam, Tanzania

Location

Related Publications (1)

• Mbwambo J, Kaaya S, Lema I, Burant CJ, Magwiza C, Madundo K, Njiro G, Blixen CE, Cassidy KA, Levin JB, Sajatovic M. 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. BMC Psychiatry. 2022 Jan 27;22(1):62. doi: 10.1186/s12888-022-03695-8.

  PMID: 35086504 DERIVED

MeSH Terms

Conditions

Schizophrenia; Medication Adherence; Psychotic Disorders

Interventions

haloperidol decanoate; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Limitations and Caveats

The small sample size, single-site enrollment, and the fact that poor medication adherence was one of the inclusion criterion may make findings less generalizable to the full spectrum of patients with CPD in Tanzania. Additionally, since we did not collect data on family burden, it is not possible to make any conclusions regarding how CAE-L may impact families and communities.

Results Point of Contact

• Title: Kaylee Sarna
• Organization: Case Western Reserve University

kns17@case.edu

(216) 368-3577

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and of Neurology

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: November 5, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)