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

NCT02462473 | Terminated Phase 2 Results

• 2 other identifiers: CR106922CODX0001NAP2002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Aripiprazole; Olanzapine; Paliperidone; Quetiapine; Risperidone; Liquid Chromatography-Tandem Mass Spectrometry

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Medication Treatment Modifications (MTM)

  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.

  Up to Week 12

Secondary Outcomes (7)

• Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12

  Week 0, Week 12

• Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12

  Week 0, Week 12

• Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12

  Week 12

• Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)

  Up to Week 12

• Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12

  Week 0, Week 12

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in this cohort at a given site have completed their study participation.

Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone

Cohort 2

EXPERIMENTAL

Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will be provided to the clinician as they become available.

Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone

Cohort 3

EXPERIMENTAL

Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in cohorts 2 and 3 at a given site have completed participation in the active assessment phase.

Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone

Interventions

Aripiprazole DRUG

Participants will receive aripiprazole at a dose of 5 milligram (mg) or higher, as oral formulation once daily for 12 weeks as part of participant treatment.

Cohort 1; Cohort 2; Cohort 3

Olanzapine DRUG

Participants will receive olanzapine at a dose of 5 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.

Cohort 1; Cohort 2; Cohort 3

Paliperidone DRUG

Participants will receive paliperidone 3 mg or higher dose as oral formulation once daily or 39 mg or higher dose once every 4 weeks for 12 weeks as part of participant treatment.

Cohort 1; Cohort 2; Cohort 3

Quetiapine DRUG

Participants will receive quetiapine at a dose of 150 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.

Cohort 1; Cohort 2; Cohort 3

Risperidone DRUG

Participants will receive risperidone 1 mg or higher dose, as oral formulation once daily or as injection of 12.5 mg or higher dose once every 2 weeks for 12 weeks as part of participant treatment.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Conshohocken, Pennsylvania, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Olanzapine; Paliperidone Palmitate; Quetiapine Fumarate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Isoxazoles; Azoles; Pyrimidines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Pyrimidinones

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.

Results Point of Contact

• Title: DIRECTOR CLINICAL RESEARCH
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (3)