A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry

Schizophrenia Clinical Trial

Official title:

A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462473
• Other study ID #: CR106922
• Secondary ID: CODX0001NAP2002
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2015
• Last updated: April 8, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels (AMPL) results are available compared to when AMPL results are not available.

Description:

This is a naturalistic, open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study), pilot clinical utility study with a sequential and parallel cohort design in participants with a diagnosis of schizophrenia or schizoaffective disorder. The study consists of up to 3 Phases: Screening Phase (Screening and first assessment visit should preferably take place on the same day), active assessment phase (12 weeks, An optional 12 week extension phase. Participants will be assigned to Cohort 1, or randomized to Cohort 2 or Cohort 3. Participants in cohorts 2 and 3 who are receiving long acting injectable (LAI) formulations of paliperidone and/or risperidone and complete participation in the active assessment phase) will have the option of continuing into the extension phase. The duration of study participation will be approximately 12 weeks. Participants in the optional extension phase will have an additional 12 weeks of study participation. The primary outcome will be measured by the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit. Participants' safety will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participant has a diagnosis of schizophrenia (Code 295.90) or schizoaffective disorder (Code 295.70) according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM 5), based on history and clinical assessment by the investigator

• Participant has current active medication management issues and has experienced a medication treatment modification within the 6 weeks prior to Screening

• Participant is currently taking one or more of the following antipsychotic medications for at least 1 week for oral antipsychotics and at least 1 injection cycle for long-acting injectable (LAI) antipsychotics. In addition, the treating clinician plans to continue the antipsychotic medication(s) for at least 4 weeks subsequent to the Screening visit. Participant may be taking more than one formulation of a particular medication (such as oral and LAI) at or above the minimum dose specified in protocol. Qualifying formulations of the antipsychotic medications are: Aripiprazole (oral formulation only), Olanzapine (oral formulation only), Paliperidone (oral and/or LAI formulations), Quetiapine (oral formulation only), and Risperidone (oral and/or LAI formulations)

• Participant has had no clinically significant suicidal behavior or ideation during the week prior to Screening, according to the investigator's judgment

• Participant is generally healthy and has no clinically significant or unstable medical problems as determined by the investigator, except for the indication for which the antipsychotic treatment is being prescribed. This determination must be recorded in the participant's source documents and initialed by the investigator

Exclusion Criteria:

• Participant has been attending the outpatient psychiatric clinic for more than 12 months since the last psychiatric hospitalization

• During Screening, participant has active alcohol or substance use disorder (except tobacco) of moderate or severe severity according to DSM 5 criteria

• Participant has a history of or currently has a clinically significant (particularly unstable) medical illness, other than the indication for which the participant is taking antipsychotic therapy, that the investigator considers should exclude the participant or that could interfere with the participant completing the study or with interpretation of the study results. Treated, stable, chronic medical problems are allowed, as long as these conditions do not interfere with the study assessments

• Participant is receiving clozapine

• Participant has donated blood or blood products or had substantial loss of blood (ie, blood loss of approximately more than 450 milliliter (mL) or blood loss that required a blood transfusion) within 1 month of Screening or has the intention to donate blood or blood products during the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole
Participants will receive aripiprazole 5 milligram (mg) oral formulation once daily for 12 weeks as part of participant treatment.
• Olanzapine
Participants will receive olanzapine 5 mg oral formulation once daily for 12 weeks as part of participant treatment.
• Paliperidone
Participants will receive paliperidone 3 mg oral formulation once daily or 39 mg once every 4 weeks for 12 weeks as part of participant treatment.
• Quetiapine
Participants will receive quetiapine 150 mg oral formulation once daily for 12 weeks as part of participant treatment.
• Risperidone
Participants will receive risperidone 1 mg oral formulation once daily or 12.5 mg injection once every 2 weeks for 12 weeks as part of participant treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Medication Treatment Modifications (MTM) at Every Visit From Week 0 to Week 12	Information on MTMs will be derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP will capture changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP is comprised of 3 sections covering several parameters. The CASP will capture changes in treatment options which will be used to compute MTM (Section 1), as well as factors in clinical decision making (Section 2) and the influence of antipsychotic medication plasma levels (AMPL), when they are available, on clinical decision making (Section 3).	Baseline to Week 12	No
Secondary	Overall Change in Symptom Severity From Baseline to Week 12	The overall change in symptom severity will be assessed using the Clinical Global Impression-Severity (CGI-S) rating scale. The CGI-S is 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).	Baseline to Week 12	No
Secondary	Overall Change in Symptom Severity Across Different Domains of Psychosis From Baseline to Week 12	The overall change in symptom severity across different domains of psychosis will be assessed using the dimensions of psychosis severity scale (DPSS). The DPSS was developed for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for clinicians to rate 8 domains commonly seen in participants with psychotic disorders. Each item is rated on a scale of 0 to 4 with anchored description of endpoints.	Baseline to Week 12	No
Secondary	Impact of the Clinician's Knowledge of Antipsychotic Medication Plasma Levels (AMPL)	Impact of the clinician's knowledge of AMPL on future AMPL results as a result of clinical decisions will be assessed through an analysis of the longitudinal AMPL results.	Baseline to Week 12	No
Secondary	Clinical Assessment of the Schizophrenia Patient (CASP)	The CASP and data on concomitant medications and psychosocial treatments will be used to evaluate the impact of AMPL results on other aspects of clinical decision making.	Baseline to Week 12	No
Secondary	Change in Clinician's Rating Scale of adherence (CRS) Score	The CRS will be used to evaluate a clinician's ability to assess the level of treatment adherence by the participant and the clinician's confidence in this assessment based on AMPL results. The CRS is an ordinal scale ranging from 1 to 7 that is used to quantify the clinician's assessment of the level of treatment adherence by the participant. Higher numbers indicate greater adherence.	Baseline to Week 12	No
Secondary	Change in Brief Adherence Rating Scale (BARS) Visual Analog Score	The BARS will be used to capture a participant's confidential report of adherence. The BARS was adapted from the CATIE study and is a 4 item scale that includes 3 questions and an overall visual analog rating scale that assesses the participant's knowledge about his/her medication.	Baseline to Week 12	No
Secondary	Change From Baseline in Patient Satisfaction Scale (PSS) Total Score	The PSS will be used to evaluate if the participant's satisfaction with treatment is impacted by the availability of AMPL results. The PSS is a brief scale designed to capture a psychiatric participant'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 (6 items). All but the last item 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.	Baseline to Week 12	No