Trial Outcomes & Findings for Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (NCT NCT01152697)

NCT ID: NCT01152697

Last Updated: 2014-12-30

Results Overview

Subjects will be asked how many days they have been homeless

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline-25 weeks
• Results posted on: 2014-12-30

Participant Flow

Participant milestones

Measure	Patient Noncompliance Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
Overall Study STARTED	30
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic

Baseline characteristics by cohort

Measure	Patient Noncompliance n=30 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Age, Continuous	41.77 years STANDARD_DEVIATION 8.59 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline-25 weeks

Population: 26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25.

Subjects will be asked how many days they have been homeless

Outcome measures

Measure	Patient Noncompliance n=26 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks Baseline	6.50 days Standard Deviation 7.73
Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks 25 Weeks	9.85 days Standard Deviation 13.96

PRIMARY outcome

Timeframe: Baseline-25 weeks

Population: 17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25.

A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.

Outcome measures

Measure	Patient Noncompliance n=17 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks Past week	30.91 Percentage of doses Standard Deviation 34.50
Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks Past month	10.10 Percentage of doses Standard Deviation 16.70

PRIMARY outcome

Timeframe: Baseline-25 weeks

Population: 15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25.

Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=15 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks Baseline	7.47 units on a scale Standard Deviation 1.84
Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks Week 25	8.07 units on a scale Standard Deviation 1.03

PRIMARY outcome

Timeframe: Baseline-25 weeks

Population: 16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25.

Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=16 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks Baseline	2.31 units on a scale Standard Deviation 1.20
Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks Week 25	1.19 units on a scale Standard Deviation 1.47

PRIMARY outcome

Timeframe: Baseline-25 weeks

Population: 19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes.

Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=19 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks Baseline	6.63 units on a scale Standard Deviation 3.44
Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks Week 25	4.47 units on a scale Standard Deviation 3.29

SECONDARY outcome

Timeframe: Month 1-3, Month 10-12

Population: Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes.

The frequency of health resource use will be measured through interview of the participant.

Outcome measures

Measure	Patient Noncompliance n=3 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Frequency of Health Resource Use Throughout Months 10, 11, and 12 3 Month	19.33 days Standard Deviation 27.65
Frequency of Health Resource Use Throughout Months 10, 11, and 12 12 Month	15.50 days Standard Deviation 20.51

SECONDARY outcome

Timeframe: Baseline-25 weeks

Population: 19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25.

The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.

Scale Range: 18-126 Lower scores represent improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=19 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks Baseline	46.37 units on a scale Standard Deviation 9.87
Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks Week 25	32.84 units on a scale Standard Deviation 10.03

SECONDARY outcome

Timeframe: Baseline-25 weeks

Population: 17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25.

Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.

Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)

Outcome measures

Measure	Patient Noncompliance n=17 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks Baseline - Severity	4.76 units on a scale Standard Deviation 0.83
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks Week 25 - Severity	3.24 units on a scale Standard Deviation 0.75
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks Baseline - Global Improvement	3.43 units on a scale Standard Deviation 0.98
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks Week 25 - Global Improvement	2.14 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline-25 weeks

Population: 17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25.

Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=17 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks Baseline	47.35 units on a scale Standard Deviation 6.92
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks Week 25	58.65 units on a scale Standard Deviation 10.05

SECONDARY outcome

Timeframe: 25 weeks

Population: 17 participants were administered and completed this measure at week 25.

Satisfaction will be measured by a seven item inventory taken by the participant.

Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.

Outcome measures

Measure	Patient Noncompliance n=17 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks	12.12 units on a scale Standard Deviation 3.92

SECONDARY outcome

Timeframe: Baseline-25 weeks

Population: 19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25.

The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.

There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.

Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes.

Outcome measures

Measure	Patient Noncompliance n=19 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks Baseline	46.37 units on a scale Standard Deviation 9.87
Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks Week 25	32.84 units on a scale Standard Deviation 10.03

SECONDARY outcome

Timeframe: 25 weeks

Population: 17 participants were administered and completed this measure at week 25.

The frequency of health resource use will be measured through interview of the participant.

Outcome measures

Measure	Patient Noncompliance n=17 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks	20.18 days Standard Deviation 35.92

SECONDARY outcome

Timeframe: 12 months

Population: 12 participants were administered and completed measurement with the CGI at 12 months.

Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.

Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)

Outcome measures

Measure	Patient Noncompliance n=12 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months Severity	3.17 units on a scale Standard Deviation 0.84
Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months Global Improvement	2.42 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline-12 months

Population: Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months.

Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=6 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months Baseline	45.33 units on a scale Standard Deviation 5.13
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months 12 months	63.83 units on a scale Standard Deviation 10.53

SECONDARY outcome

Timeframe: 12 months

Population: Six participants were administered and completed this measure at 12 months.

Satisfaction will be measured by a seven item inventory taken by the participant.

Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.

Outcome measures

Measure	Patient Noncompliance n=6 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months	12.33 units on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: 12 months

Population: Six participants were administered and completed this measure at 12 months.

Subjects will be asked how many days they have been homeless

Outcome measures

Measure	Patient Noncompliance n=5 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Days Homeless Out of the Previous 6 Months as Measured at 12 Months	35 days Standard Deviation 47.96

SECONDARY outcome

Timeframe: 12 months

Population: Seven participants were administered and completed this measure at 12 months.

A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.

Outcome measures

Measure	Patient Noncompliance n=7 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Treatment Adherence Score as Measured at 12 Months Past Week	28.65 Percentage of doses Standard Deviation 34.03
Treatment Adherence Score as Measured at 12 Months Past Month	6 Percentage of doses Standard Deviation 7.48

SECONDARY outcome

Timeframe: 12 months

Population: Six participants were administered and completed this measure at 12 months.

Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=6 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months	7.00 units on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: 12 months

Population: Six participants were administered and completed this measure at 12 months.

Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.

Outcome measures

Measure	Patient Noncompliance n=6 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months	1.33 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 12 months

Population: Seven participants were administered and completed this measure at 12 months.

Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.

Outcome measures

Measure	Patient Noncompliance n=7 Participants Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months	2.43 units on a scale Standard Deviation 1.27

Adverse Events

Patient Noncompliance

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patient Noncompliance n=30 participants at risk Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
Cardiac disorders Abnormal EKG	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Stomach Cramps	3.3% 1/30 • Number of events 1
Cardiac disorders High Blood Pressure	3.3% 1/30 • Number of events 1
Infections and infestations Toothache and Infection	3.3% 1/30 • Number of events 1
Infections and infestations Infection in Leg	3.3% 1/30 • Number of events 1
Infections and infestations Complications from Colostomy Surgery	3.3% 1/30 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Martha Sajatovic, Professor of Psychiatry

University Hospitals of Cleveland

Phone: 2168442808

Email: martha.sajatovic@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place