Trial Outcomes & Findings for A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry (NCT NCT02462473)
NCT ID: NCT02462473
Last Updated: 2017-03-29
Results Overview
Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.
TERMINATED
PHASE2
9 participants
Up to Week 12
2017-03-29
Participant Flow
The study had a planned enrollment of approximately 155 participants into 3 cohorts. However a total of 9 participants were enrolled and analyzed for efficacy and safety assessments in Cohort 1 and no participants were enrolled into Cohorts 2 or 3 of the study.
Participant milestones
| Measure |
Cohort 1
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
Baseline characteristics by cohort
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 13.15 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Number of Participants With Medication Treatment Modifications (MTM)
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 0, Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.
Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 1 (Week 0)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 1 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 2 (Week 0)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 2 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 3 (Week 0)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 3 (Week 12)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 4 (Week 0)
|
5 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 5 (Week 0)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 5 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 6 (Week 0)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 6 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 7 (Week 0)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 7 (Week 12)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 8 (Week 0)
|
4 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 8 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 9 (Week 12)
|
3 units on a scale
|
|
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Participant 9 (Week 0)
|
3 units on a scale
|
SECONDARY outcome
Timeframe: Week 0, Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.
The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0-32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 1 (Week 0)
|
12 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 1 (Week 12)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 2 (Week 0)
|
8 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 2 (Week 12)
|
2 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 3 (Week 0)
|
8 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 3 (Week 12)
|
8 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 4 (Week 0)
|
14 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 5 (Week 0)
|
9 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 5 (Week 12)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 6 (Week 0)
|
7 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 6 (Week 12)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 7 (Week 0)
|
5 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 7 (Week 12)
|
8 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 8 (Week 0)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 8 (Week 12)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 9 (Week 0)
|
4 units on a scale
|
|
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Participant 9 (Week 12)
|
6 units on a scale
|
SECONDARY outcome
Timeframe: Week 12Population: AMPL analysis set included all enrolled participants who had AMPL data for at least 1 visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
AMPL of the individual participant during the active assessment phase was reported.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 1- ARIPIPRAZOLE
|
596.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 1- DEHYDROARIPIPRAZOLE
|
139.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 2- OLANZAPINE
|
27.30 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 2- PALIPERIDONE
|
45.10 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 3- 7-OH QUETIAPINE
|
43.10 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 3-NORQUETIAPINE
|
660.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 3-QUETIAPINE
|
280.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 3-QUETIAPINE SULFOXIDE
|
660.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 5-7-OH QUETIAPINE
|
7.72 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 5-NORQUETIAPINE
|
153.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 5-QUETIAPINE
|
50.30 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 5-QUETIAPINE SULFOXIDE
|
321.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 6-ARIPIPRAZOLE
|
464.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 6-DEHYDROARIPIPRAZOLE
|
112.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 7-PALIPERIDONE
|
31.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 7-RISPERIDONE
|
26.20 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- PALIPERIDONE
|
0.100 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- QUETIAPINE
|
2.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- QUETIAPINE SULFOXIDE
|
2.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- RISPERIDONE
|
0.100 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 8-ARIPIPRAZOLE
|
168.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 8-DEHYDROARIPIPRAZOLE
|
33.00 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- 7-OH QUETIAPINE
|
0.200 nanogram per milliliter
|
|
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Participant 9- NORQUETIAPINE
|
2.00 nanogram per milliliter
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Side Effects Of Medication
|
3 participants
|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Attitude Toward Treatment
|
2 participants
|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Report of Increased Symptoms
|
4 participants
|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Report of Decrease in Symptoms
|
3 participants
|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Patient Still Symptomatic
|
1 participants
|
|
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Patient Ideation
|
1 participants
|
SECONDARY outcome
Timeframe: Week 0, Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.
The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician's assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 9 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 1 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 1 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 2 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 2 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 3 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 3 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 4 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 5 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 5 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 6 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 6 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 7 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 7 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 8 (Week 0)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 8 (Week 12)
|
7 units on a scale
|
|
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Participant 9 (Week 0)
|
7 units on a scale
|
SECONDARY outcome
Timeframe: Week 0, Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.
The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant's knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent \[%\] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 1 (Week 0)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 1 (Week 12)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 2 (Week 0)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 2 (Week 12)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 3 (Week 0)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 3 (Week 12)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 4 (Week 0)
|
97 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 5 (Week 0)
|
93 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 5 (Week 12)
|
90 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 6 (Week 0)
|
90 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 6 (Week 12)
|
96 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 7 (Week 0)
|
90 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 7 (Week 12)
|
95 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 8 (Week 0)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 8 (Week 12)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 9 (Week 0)
|
100 percent adherence
|
|
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Participant 9 (Week 12)
|
100 percent adherence
|
SECONDARY outcome
Timeframe: Week 0, Week 12Population: All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.
The PSS is a brief scale designed to capture a psychiatric patient's satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 1 (Week 0)
|
76 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 1 (Week 12)
|
76 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 2 (Week 0)
|
52 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 2 (Week 12)
|
57 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 3 (Week 0)
|
57 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 3 (Week 12)
|
57 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 4 (Week 0)
|
48 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 5 (Week 0)
|
66 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 5 (Week 12)
|
64 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 6 (Week 0)
|
76 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 6 (Week 12)
|
76 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 7 (Week 0)
|
76 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 7 (Week 12)
|
72 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 8 (Week 0)
|
63 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 8 (Week 12)
|
72 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 9 (Week 0)
|
71 units on a scale
|
|
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Participant 9 (Week 12)
|
76 units on a scale
|
Adverse Events
Cohort 1
Serious adverse events
| Measure |
Cohort 1
n=9 participants at risk
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
General disorders
Death
|
11.1%
1/9
|
Other adverse events
| Measure |
Cohort 1
n=9 participants at risk
Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
|
|---|---|
|
Ear and labyrinth disorders
External ear inflammation
|
11.1%
1/9
|
|
Infections and infestations
Pharyngitis
|
11.1%
1/9
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9
|
|
Psychiatric disorders
Depression
|
11.1%
1/9
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
11.1%
1/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER