Trial · NCT02462473
A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
NCT02462473, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry. Trials, record NCT02462473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02462473
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
- NCT number
- NCT02462473
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Aripiprazole, Olanzapine, Paliperidone, Quetiapine, Risperidone
- First posted
- 2015-06-04
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
- Limitations and caveats
- Due to poor enrollment, the study was terminated early by the sponsor after enrolling only 9 participants in Cohort 1 and no participants were enrolled in Cohorts 2 and 3.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Medication Treatment Modifications (MTM) | Up to Week 12 | 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. |
| Secondary | Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Week 0, Week 12 | 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. |
| Secondary | Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12 | Week 0, Week 12 | 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. |
| Secondary | Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12 | Week 12 | AMPL of the individual participant during the active assessment phase was reported. |
| Secondary | Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP) | Up to Week 12 | 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. |
| Secondary | Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12 | Week 0, Week 12 | 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. |
| Secondary | Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12 | Week 0, Week 12 | 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. |
| Secondary | Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12 | Week 0, Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Medication Treatment Modifications (MTM) | Up to Week 12 | 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. | Participants | NUMBER |
| SECONDARY | Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Week 0, Week 12 | 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. | units on a scale | NUMBER |
| SECONDARY | Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12 | Week 0, Week 12 | 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. | units on a scale | NUMBER |
| SECONDARY | Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12 | Week 12 | 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. | nanogram per milliliter | NUMBER |
| SECONDARY | Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP) | Up to Week 12 | 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. | participants | NUMBER |
| SECONDARY | Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12 | Week 0, Week 12 | 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. | units on a scale | NUMBER |
| SECONDARY | Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12 | Week 0, Week 12 | 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. | percent adherence | NUMBER |
| SECONDARY | Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12 | Week 0, Week 12 | 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. | units on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Medication Treatment Modifications (MTM) | Cohort 1 | 4 | Participants | ||
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 1 (Week 0) | 4 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 1 (Week 12) | 3 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 2 (Week 0) | 4 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 2 (Week 12) | 3 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 3 (Week 0) | 4 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 3 (Week 12) | 4 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 4 (Week 0) | 5 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 5 (Week 0) | 3 | units on a scale | |
| Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12 | Cohort 1 | Participant 5 (Week 12) | 3 | units on a scale |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 9 | |
| Overall Study | COMPLETED | Cohort 1 | 5 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 4 |
Source ClinicalTrials.gov
Adverse events7
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 | External ear inflammation | Ear and labyrinth disorders | Cohort 1 | 1 | 9 | |
| other | Pharyngitis | Infections and infestations | Cohort 1 | 1 | 9 | |
| other | Anxiety | Psychiatric disorders | Cohort 1 | 1 | 9 | |
| other | Depression | Psychiatric disorders | Cohort 1 | 1 | 9 | |
| other | Restlessness | Psychiatric disorders | Cohort 1 | 1 | 9 | |
| other | Miliaria | Skin and subcutaneous tissue disorders | Cohort 1 | 1 | 9 | |
| serious | Death | General disorders | Cohort 1 | 1 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, other adverse events | Cohort 1 | 4 | 9 |
| Total, serious adverse events | Cohort 1 | 1 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02462473
GET https://conductscience.org/api/trials/v1/NCT02462473/results?page=2