Table 1.

Summary of orally disintegrating olanzapine clinical efficacy/effectiveness studies

Citation	Study design	Location	Patients	Intervention/treatment	Outcomes
Single-arm studies
Chue et al22	Pilot intervention study, open-label, 7 days follow-up	Canada, singlecenter, outpatient	Schizophrenia Stable on SOT for at least 7 days N = 11	ODO 5–20 mg/day; mean = 12.7 (SD 5.2) mg/day	Safety: adverse events Acceptance: questionnaire
Kinon et al38	Interventional study, open-label, 6 weeks follow-up	Multicenter, inpatient/outpatient	Schizophrenia, schizoaffective disorder, or schizophreniform disorder BPRS1-7 ≥ 42 and CGI-S ≥ 4 Noncompliant based on a priori criteria N = 85	ODO 10 mg/day starting dose then up to 20 mg/day. Patients could change to SOT after 1 week. Mean at endpoint (LOCF) for those remaining on ODO (N = 49) = 14.8 (SD 4.2) mg/day	Efficacy: PANSS, CGI Safety: BAS, AIMS, modified SAS, adverse events Acceptance: ROMI, TCI, NAMA
Dardennes et al37	Prospective observational, 6 weeks follow-up	France, inpatient	Schizophrenia and schizophreniform disorder Acute psychotic episode N = 512	ODO mean = 16.2 (SD 7.9) mg/day at treatment initiation and 19.1 (SD 10.5) at the end of week 1	Efficacy: CGI-S, CGI-I, PANSS Acceptance: patient and nursing questionnaires, nursing burden, VAS (psychiatrist satisfaction)
Van Heeringen et al39	Retrospective observational, previous 2-month period	Belgium, inpatient/outpatient	Schizophrenia, bipolar disorder, others (dementia, alcohol intoxication, substance abuse, and personality disorders) With/without agitation, refused other oral medication N = 548	ODO monotherapy or combination therapy, 2.5–40, median = 20, mean = 18.2 (SD 8.9) mg/day	Efficacy: CGI-S, CGI-I, ACES, VAS (cooperation) Acceptance: nurses’ workload (physician rated), intramuscular injection
Hori et al36	Interventional study, open-label, 4 weeks follow-up	Japan	First-episode schizophrenia N = 53	ODO 10 mg/day starting dose then flexible (dose not reported)	Efficacy: PANSS-EC, PANSS-CI Safety: DIEPSS Acceptance: NAMA
Damodaran et al29	Prospective observational study, 1 week follow-up	Australia, multicenter, inpatient	Schizophrenia, schizophreniform disorder, schizoaffective disorder N = 104	ODO mean = 17.4 (SD 7.4) mg/day; SOT mean = 16.8 (SD 6.1) mg/day (at endpoint)	Efficacy: PANSS-Neg, PANSS-EC, CGI-S
Czekalla et al30	Prospective observational study, 2 weeks follow-up	Germany, multicenter, hospital setting	Patients arriving at the 24-hour emergency-service of psychiatric care hospitals with a tentative diagnosis of acute schizophrenia or other psychiatric disorder N = 456	ODO 2.5–60, mean = 18.2 (SD 7.7) mg/day; SOT 2.5–40, mean = 16.9 (SD 7.8) mg/day (at endpoint)	Efficacy/functioning: CGI-S, CGI-I, MADRS Safety: adverse events Acceptance: NAMA
Pascual et al13	Prospective observational study, 6 hours follow-up	Spain, psychiatric emergency room	Acutely agitated psychotic patients PANSS-EC ≥ 20, CGI-S ≥ 5 N = 80	ODO 20 mg (single dose), conventional oral therapy	Efficacy: PANSS-EC, ACES, with/without pharmacological intervention, with/without physical restraint Safety: vital signs, adverse events, modified UKU
Arranz et al35	Posthoc analysis, prospective, openlabel, randomization to antipsychotic and chronological sequential assignment to SOT and ODO, 6 weeks follow-up	Spain, hospital setting	First-episode (never treated) paranoid schizophrenia, schizophreniform, schizoaffective, acute psychoses, psychotic disorder not otherwise specified, bipolar disorder N = 38	ODO mean = 15.8 (SD 8) mg/day; SOT mean = 13.8 (SD 6) mg/day	Efficacy: PANSS total Safety: body weight, body mass index
Hatta et al33	Pseudorandomized, open-label, measurements recorded every 15 minutes for 1 hour	Japan, multicenter, psychiatric emergency departments	Acutely psychotic and agitated patients with PANSS-EC ≥ 15 N = 87	ODO mean = 10.4 (SD 3.3) mg/day; RIS-OS mean = 3.3 (SD 2.6) mg/day	Efficacy: PANSS-EC, CGI-S, need for injection due to worsening Acceptance: treatment satisfaction question (patient) Safety: physiological parameters, DIEPSS
Kuramochi et al31	Posthoc analysis of postmarketing surveillance prospective observational study, 6 weeks follow-up	Japan, multicenter	Acute-stage schizophrenia N = 1068	ODO mean = 12.4 (SD 6.0) mg/day; SOT mean = 10.2 (SD 5.4) mg/day (initial dose)	Efficacy: BPRS (total and positive symptom subscale), CGI-S schizophrenia
Karagianis et al27	Intervention study, randomized, doubleblind, double-dummy, 16 weeks follow-up	Canada, the US, the Netherlands, and Mexico, multicenter, outpatient	Schizophrenia, schizoaffective disorder, schizophreniform, bipolar disorder, other psychotic disorder Taking SOT for 4–52 weeks Experienced significant weight gain (≥5 kg) N = 149	ODO 5–20 (sublingual), mean = 14.3 mg/day; SOT 5–20, mean = 14.9 mg/day (at 12–16 weeks)	Efficacy/functioning: CGI-S, GAF, SWN-S Safety: body mass index, weight, cardiometabolic parameters, VAS (appetite) Adherence: pill count
Bitter et al28	Intervention study, randomized, openlabel, crossover, 6 weeks follow-up per treatment (12 weeks total)	Turkey, Israel, Romania, Mexico, Brazil, multicenter, outpatient	Schizophrenia Stable for at least 4 weeks prior to screening Able to take olanzapine at dose of 5–20 mg/day N = 265	ODO 5–20, mean = 12.3 mg/day; SOT 5–20, mean = 12.4 mg/day	Efficacy/functioning: CGI-S Safety: ADMP-5, laboratory tests, physical examination, VAS (appetite), adverse events Acceptance: DAI-10 Adherence: MAF Preference: three-choice question
Chartier et al32	Prospective observational study, 1 year follow-up	Greece, France, Germany, multicenter, outpatient	Schizophrenia, bipolar disorder N = 903	Schizophrenia: ODO mean = 16.0 (SD 7.0) mg/day; SOT mean = 11.9 (SD 5.6) mg/day Bipolar disorder: ODO mean = 13.1 (SD 7.0); SOT mean = 9.6 (SD 4.9) mg/day (endpoint LOCF)	Efficacy: CGI-S, GAF, PGWBI Adherence: MARS Acceptance: WAI-physician, SUMD-A
Hsu et al34	Prospective, randomized, raterblinded, 24 hours follow-up	Taiwan, acute care psychiatric inpatient ward	DSM-IV-TR diagnosis of schizophrenia, bipolar disorder, schizoaffective disorder, delusional disorder, other psychotic disorder PANSS-EC ≥ 14 ge;4 for at least one PANSS-EC item N = 42 (completers)	Intramuscular olanzapine 10 mg; ODO 10 mg; RIS-OS 3 mg; intramuscular haloperidol 7.5 mg	Efficacy: PANSS-EC, ACES, CGI-S Safety: adverse events

Abbreviations: ACES, Agitation Calmness Evaluation Scale; ADMP-5, Association for Methodology and Documentation in Psychiatry; AIMS, Abnormal Involuntary Movement Scale; BAS, Barnes Akathisia Scale; BPRS, Brief Psychiatric Rating Scale, CGI, Clinical Global Impression scale; CGI-I, CGI-Improvement scale; CGI-S, Clinical Global Impression-Severity scale; DAI-10, Drug Attitude Inventory; DIEPSS, Drug-Induced Extrapyramidal Symptoms Scale; DSM-IV-TR, text revision of Diagnostic and Statistical Manual of Mental Disorders, 4th ed (Arlington: American Psychiatric Association; 2000). GAF, Global Assessment of Functioning scale; LOCF, last observation carried forward; MADRS, Montgomery Asberg Depression Rating Scale; MAF, Medication Adherence Form; MARS, Medication Adherence Rating Scale; NAMA, Nursing Assessment of Medication Acceptance scale; ODO, oral-disintegrating olanzapine; PANSS, Positive and Negative Syndrome Scale; PANSS-CI, PANSS-Complementary Items; PANSS-EC, PANSS-Excited Component; PANSS-Neg, PANSS-negative symptoms; PGWBI, Psychological General Wellbeing Index; RIS-OS, risperidone oral solution; ROMI, Rating of Medication Influences; SAS, Simpson–Angus Scale; SD, standard deviation; SOT, standard olanzapine-coated tablet; SUMD-A, Scale to Assess Unawareness of Mental Disorder; SWN-S, Subjective Wellbeing Under Neuroleptics scale; TCI, Treatment Compliance Interview; UKU, Udvalg for Kliniske Undersøgelser Side Effect Rating Scale; VAS, Visual Analog Scale; WAI, Working Alliance Inventory.