Trial · NCT04327843
Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
NCT04327843, Phase 3, Completed, Case Western Reserve University; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY). Trials, record NCT04327843. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04327843
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
- NCT number
- NCT04327843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Case Western Reserve University
- Conditions
- Schizophrenia, Medication Nonadherence, Schizo Affective Disorder
- Interventions
- Customized Adherence Enhancement, Haloperidol Decanoate
- First posted
- 2020-03-31
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-12
- 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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tablets Routine Questionnaire (TRQ) | Change from Baseline to 6 month visit | 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). |
| Primary | Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: | Baseline to 6 month visit | 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). |
| Secondary | Drug Attitude Inventory (DAI) | Baseline to 6 month visit | 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. |
| Secondary | Brief Psychiatric Rating Scale (BPRS) | Baseline to 6 month visit | 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. |
| Secondary | Clinical Global Impressions (CGI) | Baseline to 6 month visit | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. |
| Secondary | Social and Occupational Functioning Scale (SOFAS) | Baseline to 6 month visit | 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. |
| Secondary | Body Mass Index | Baseline to Month 6(week 25) | Body Mass Index kg/m\^2 of participants |
| Secondary | ESRS-A Parkinsonism | Baseline to 6 months(25 weeks) | 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. |
| Secondary | ESRS-A Dystonia | Baseline to 6 months(25 weeks) | 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. |
| Secondary | ESRS-A Dyskinesia | Baseline to 6 months(25 weeks) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tablets Routine Questionnaire (TRQ) | Change from Baseline to 6 month visit | Since participants stopped using oral medications once they were stable on LAI, there were only two participants remaining at 25 Week visit and therefore analysis was not done. As only 2 individuals were on concommittent oral CPD medication at 25 week follow up, mean change in TRQ was not calculated. This was just done to enter into clinical trials. | percentage of change in adherence | MEAN |
| PRIMARY | Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: | Baseline to 6 month visit | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). LAI injection frequency was 100%. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Drug Attitude Inventory (DAI) | Baseline to 6 month visit | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
| SECONDARY | Brief Psychiatric Rating Scale (BPRS) | Baseline to 6 month visit | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
| SECONDARY | Clinical Global Impressions (CGI) | Baseline to 6 month visit | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | units on a scale | MEAN |
| SECONDARY | Social and Occupational Functioning Scale (SOFAS) | Baseline to 6 month visit | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
| SECONDARY | Body Mass Index | Baseline to Month 6(week 25) | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | kg/m^2 | MEAN |
| SECONDARY | ESRS-A Parkinsonism | Baseline to 6 months(25 weeks) | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
| SECONDARY | ESRS-A Dystonia | Baseline to 6 months(25 weeks) | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
| SECONDARY | ESRS-A Dyskinesia | Baseline to 6 months(25 weeks) | Poorly adherent patients with schizophrenia who received long-acting injectable antipsychotic medication and a customized adherence enhancement behavioral intervention (CAE-L). | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tablets Routine Questionnaire (TRQ) | CAE + LAI Treatment | TRQ Week adherence | -57 | Standard Deviation 60.8 | percentage of change in adherence |
| Tablets Routine Questionnaire (TRQ) | CAE + LAI Treatment | TRQ Month adherence | -23 | Standard Deviation 0 | percentage of change in adherence |
| Long-Acting Injectable Adherence (LAI Adherence): Count of Participants Who Received All LAI Injections: | CAE + LAI Treatment | 18 | Participants | ||
| Drug Attitude Inventory (DAI) | CAE + LAI Treatment | Baseline | 7.89 | Standard Deviation 2.72 | score on a scale |
| Drug Attitude Inventory (DAI) | CAE + LAI Treatment | 25 Weeks | 9.83 | Standard Deviation 0.52 | score on a scale |
| Brief Psychiatric Rating Scale (BPRS) | CAE + LAI Treatment | Baseline | 27.00 | Standard Deviation 10.26 | score on a scale |
| Brief Psychiatric Rating Scale (BPRS) | CAE + LAI Treatment | 25-Weeks | 25.06 | Standard Deviation 8.53 | score on a scale |
| Clinical Global Impressions (CGI) | CAE + LAI Treatment | Baseline | 2.88 | Standard Deviation 1.32 | units on a scale |
| Clinical Global Impressions (CGI) | CAE + LAI Treatment | 25 Weeks | 2.24 | Standard Deviation 1.09 | units on a scale |
| Social and Occupational Functioning Scale (SOFAS) | CAE + LAI Treatment | Baseline | 62.17 | Standard Deviation 18.28 | score on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Assessment | STARTED | CAE + LAI Treatment | 19 | |
| Baseline Assessment | COMPLETED | CAE + LAI Treatment | 19 | |
| Baseline Assessment | NOT COMPLETED | CAE + LAI Treatment | 0 | |
| Week 13 Assessment | STARTED | CAE + LAI Treatment | 19 | |
| Week 13 Assessment | COMPLETED | CAE + LAI Treatment | 19 | |
| Week 13 Assessment | NOT COMPLETED | CAE + LAI Treatment | 0 | |
| Week 25 Assessment | STARTED | CAE + LAI Treatment | 19 | |
| Week 25 Assessment | COMPLETED | CAE + LAI Treatment | 18 | |
| Week 25 Assessment | NOT COMPLETED | CAE + LAI Treatment | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tremor | Nervous system disorders | CAE + LAI Treatment | 7 | 19 | |
| other | Drowsiness | General disorders | CAE + LAI Treatment | 6 | 19 | |
| other | Blurry vision | Eye disorders | CAE + LAI Treatment | 3 | 19 | |
| other | Restlessness | General disorders | CAE + LAI Treatment | 2 | 19 | |
| other | Muscle pain | Musculoskeletal and connective tissue disorders | CAE + LAI Treatment | 2 | 19 | |
| serious | Substance use relapse and hospitalization | Injury, poisoning and procedural complications | CAE + LAI Treatment | 1 | 19 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAE + LAI Treatment | 0 | 19 |
| Total, other adverse events | CAE + LAI Treatment | 13 | 19 |
| Total, serious adverse events | CAE + LAI Treatment | 1 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35086504 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21MH114700 | Reducing the Burden of Chronic Psychotic Disorders in Tanzania | SAJATOVIC, MARTHA X; MBWAMBO, JESSIE K | CASE WESTERN RESERVE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2017 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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