NCT06061952: CAE-S

CAE for Poorly Adherent Individuals With Schizophrenia

Completed NA Results posted Last updated 18 November 2025

What this trial tests

NA trial testing Customized Adherence Enhancement for Schizophrenia (CAE-S) in Schizophrenia in 36 participants. Completed in 9 August 2025.

Timeline

16 January 2024

Primary endpoint
9 August 2025

9 August 2025

Quick facts

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	36
Start date	16 January 2024
Primary completion	9 August 2025
Estimated completion	9 August 2025
Sites	1 location across United States

Drugs / interventions tested

• Customized Adherence Enhancement for Schizophrenia (CAE-S)
• Enhanced Treatment as Usual (eTAU)

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

University Hospitals Cleveland Medical Center

Who can join

18 and older, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks Primary · 12 weeks

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	4.89	± 1.9

Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks Primary · 12 weeks

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	93.8

Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks Secondary · 12 weeks

The PANSS is a clinician rated scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with higher scores indicating more severe schizophrenia

Baseline

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	60.9	± 10.5
Enhanced Treatment as Usual (eTAU)	66.0	± 9.7

Week 12

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	53.8	± 9.0
Enhanced Treatment as Usual (eTAU)	54.2	± 11.2

Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks Secondary · 12 weeks

The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.

Baseline

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	13.4	± 16.5
Enhanced Treatment as Usual (eTAU)	13.2	± 10.9

Week 12

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	17.9	± 28.0
Enhanced Treatment as Usual (eTAU)	8.8	± 11.0

Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks Secondary · 12 weeks

The TRQ is a validated self-report measure that identifies proportion of days with missed doses in the past 7 days (past-week) and in the past 30 days (past-month). Lower scores (a smaller proportion/percentage n of missed medication) represent better adherence, while higher scores (a larger proportion/percentage of missed medication) represent worse adherence.

Baseline

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	11.9	± 20.7
Enhanced Treatment as Usual (eTAU)	7.7	± 8.6

Week 12

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	7.4	± 8.7
Enhanced Treatment as Usual (eTAU)	5.4	± 7.0

Change in eCAP Use in the Past Week at 12 Weeks Secondary · 12 weeks

Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used to monitor the antipsychotic dosed most often (index drug). If more than one drug is dosed at the same frequency, the antipsychotic most recently added to the regimen will be the index drug.. Investigators will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.

Baseline

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	20.8	± 34.0
Enhanced Treatment as Usual (eTAU)	32.1	± 32.2

Week 12

Group	Value	95% CI
Customized Adherence Enhancement for Schizophrenia (CAE-S)	33.8	± 36.9
Enhanced Treatment as Usual (eTAU)	50	± 35.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Customized Adherence Enhancement for Schizophrenia (CAE-S)

Serious: 2/19 (11%)

Deaths: 0/19

Enhanced Treatment as Usual (eTAU)

Serious: 0/17 (0%)

Deaths: 0/17

Serious adverse events (4 terms)

Reaction	System	Customized Adherence Enhan…	Enhanced Treatment as Usua…
Hospitalization due to pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalization due to diabetes complications	Endocrine disorders	—	—
Hospitalization due to renal complications	Renal and urinary disorders	—	—
Hospitalization due to psychiatric symptoms	Psychiatric disorders	—	—

Most-reported serious reactions: Hospitalization due to pneumonia, Hospitalization due to diabetes complications, Hospitalization due to renal complications, Hospitalization due to psychiatric symptoms.

Data from ClinicalTrials.gov NCT06061952 adverse events section.

Sponsor's own description

This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.