Table 1.
Schedule of visits and assessments
| Visit | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Screening | Baseline | |||||||||
| Week | 0 | 2 | 3 | 4 | 8 | 12 | 16 | 20 | 24 | |
| Study medication period (24 weeks) | ||||||||||
| Screening and consent | ||||||||||
| Assessment of current medication | x | x | x | x | x | x | x | x | x | x |
| Informed consent | x | |||||||||
| Ongoing capacity | x | x | x | x | x | x | x | x | x | x |
| Inclusion/exclusion criteria | x | |||||||||
| Beta-HCG (females only) | x | |||||||||
| Drug dispensation (after randomisation) | x | x | x | x | x | x | x | x | x | |
| Safety | ||||||||||
| Adverse events | x | x | x | x | x | x | x | x | ||
| SAFTEE-SI | x | x | x | x | x | x | x | x | x | |
| Vitamin B12 | x | x | x | |||||||
| Efficacy | ||||||||||
| Height | x | x | ||||||||
| Body weight | x | x | x | x | x | x | x | x | x | x |
| Waist circumference and hip/waist ratio | x | x | x | x | x | x | x | x | x | |
| Blood pressure | x | x | x | x | x | x | x | x | x | |
| Fasting glucose, insulin | x | x | x | |||||||
| Fasting cholesterol, HDL, LDL, triglycerides | x | x | x | |||||||
| Haemoglobin A1c | x | x | x | |||||||
| OGTT | x | x | ||||||||
| Other | ||||||||||
| Heart rate | x | x | x | x | x | x | x | x | x | |
| PANSS | x | x | x | |||||||
| GAF | x | x | x | |||||||
| SIMPAQ/IPAQ | x | x | x | |||||||
| AQOL | x | x | x | |||||||
| TOPF | x | x | ||||||||
| CVLT-II short form | x | x | ||||||||
| Symbol Digit Modalities Test | x | x | ||||||||
| Controlled Oral Word Association Test | x | x | ||||||||
| Trail Making Test | x | x | ||||||||
| Food Craving Inventory | x | x | x | |||||||
| Other | ||||||||||
| Drug compliance | x | x | x | x | x | x | x | x | ||
| Blood (other)—FBC (including WCC, neutrophils), ELFT (including serum bicarbonate and lactate) clozapine/nor clozapine levels | x | x | x |
AQoL, Assessment of Quality of Life; CVLT-II, The California Verbal Learning Test second edition; ELFT, Electrolytes and Liver Function Tests; FBC, full blood count; GAF, Global Assessment of Functioning; HCG, human chorionic gonadotropin; HDL, high-density lipoprotein; IPAQ, International Physical Activity Questionnaire; LDL, low-density lipoprotein; OGTT, Oral Glucose Tolerance Test; PANSS, Positive and Negative Syndrome Scale; SAFTEE-SI, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry; SIMPAQ, Simple Physical Activity Questionnaire; TOPF, Test of Premorbid Functioning.