Table 1 Characteristics of the 6 Studies Comprising the Learning Dataset and the 2 Studies Used for Validation of the CART-derived Decision Tree
Discontinuation Rate, n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
Study | Duration (weeks) | Design | Outcomes | Compounds | N | n (%) | Inclusion Criteria | ||
Through Week 2 | Through Week 8 | ||||||||
Learning Data Set Studies | |||||||||
Keefe[16] | 52 | Double-blind Randomized Controlled Flex-dose | Neurocognitive; Psychosocial; Efficacy; Safety | Olanzapine Risperidone | 159 158 | 148 (47%) | Schizophrenia or schizoaffective disorder Inpatient and outpatient Age 18 to 65 Score ≥18 on the BPRS (ext) and ≥4 on ≥2 positive items of the PANSS | 19 (11%) 16 (10%) | 24 (14%) 32 (19%) |
Tran[17] | 28 | Double-blind Randomized Controlled Flex-dose | Efficacy; Safety | Olanzapine Risperidone | 172 167 | 227 (67%) | Schizophrenia, schizophreniform disorder, schizoaffective disorder Inpatient and outpatient Age 18 to 65 BPRS (ext) score ≥42 | 15 (9%) 21 (13%) | 32 (20%) 29 (18%) |
Breier[18] | 28 | Double-blind Randomized Controlled Flex-dose | Efficacy; Safety | Olanzapine Ziprasidone | 277 271 | 122 (22%) | Schizophrenia Inpatient and outpatient Age 18 to 75 Scores ≥42 on the BPRS (ext), ≥4 on ≥1 positive symptom item of the PANSS, and CGI-S rating ≥4 (moderately ill) | 27 (10%) 48 (18%) | 39 (14%) 52 (19%) |
Kinon[20] | 24 | Double-blind Randomized Controlled Flex-dose | Negative Symptoms; Functional Outcome; Efficacy; Safety | Olanzapine Quetiapine | 171 175 | 142 (41%) | Schizophrenia, schizoaffective disorder Outpatient Age 18 to 65 Score ≥4 on ≥3, or ≥5 on ≥2 of the 7 negative symptom items of the PANSS, and ≤60 (moderate difficulties) on the GAF | 13 (8%) 17 (10%) | 39 (23%) 44 (25%) |
Kinon[19] | 24 | Double-blind Randomized Controlled Fixed-dose | Depressive Symptoms; Efficacy; Safety | Olanzapine Ziprasidone | 202 192 | 62 (16%) | Schizophrenia, schizoaffective disorder Inpatient and outpatient Age 18 to 60 Scores ≥16 (mild depression) on the MADRS and ≥4 (pervasive feelings of sadness or gloominess) on item 2 (reported sadness) of the MADRS | 23 (11%) 31 (16%) | 49 (24%) 63 (33%) |
Kinon[21] | 8 | Randomized Double-blind Fixed-dose | Dose-response relationship; Efficacy; Safety | Olanzapine 10 mg 20 mg 40 mg | 199 200 200 | 486 (81%) | Schizophrenia or schizoaffective disorder Suboptimal treatment on present antipsychotic, but not treatment resistant | 83 (14%) | 109 (18%) |
Validation Studies | |||||||||
Kinon[2] | 12 | Prospective Randomized Double-blind Flex-dose Parallel | Early improvement predictive of later response | Risperidone | 628 | 438 (70%) | Schizophrenia, schizophreniform disorder, schizoaffective disorder BPRS Total ≥45; score of ≥4 (moderate) on at least two of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content; CGI-S rating ≥4 (moderately ill) Exacerbation of illness within two weeks of Visit 1 | 3 (1%) | 127 (24%) |
Kane[22] | 28 | Double-blind Randomized Controlled Flex-dose | Efficacy Safety | Olanzapine Aripiprazole | 281 285 | 415 (73%) | Schizophrenia Age 18 to 65 years Initial PANSS Total score ≥75; score of ≥4 on one of the PANSS positive, and score of ≥4 on the CGI-S; score of ≥3 on the CGI-I at Visit 2. | 27 (10%) 39 (14%) | 44 (16%) 48 (17%) |