A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole; Olanzapine; Paliperidone; Quetiapine; Risperidone
Intervention description: 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective Disorder; Aripiprazole; Olanzapine; Paliperidone; Quetiapine; Risperidone; Liquid Chromatography-Tandem Mass Spectrometry

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.
    

Eligibility criteria:

        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