Table 1.
Study Assessments and Timeline
0 week | 2, 4 & 6 w | 8 weeks | 24 weeks | 52 weeks | ||
---|---|---|---|---|---|---|
General | Demographic questionnaire | X | X1 | X3 | X3 | |
Diagnosis | MINI | X | ||||
Symptoms | Interview to rate PANSS and CAINS | X | X | X | X | |
Calgary depression scale for schizophrenia (CDSS) combined with the Montgomery Asberg Depression Scale (MADRS) | X | X | X | X | ||
Safety | Adverse symptoms checklist (SAFTEE) | X | X2 | X | X | X |
ECG | X | X | ||||
Blood test for clozapine monitoring | X | X | X | X | ||
QoL | Manchester Quality of Life Scale (MANSA) | X | X | X | X | |
Assessment of Quality of Life (AQoL) | X | X | X | X | ||
Cognition | The Wechsler test of adult reading (WTAR): Premorbid IQ | X | ||||
Wechsler abbreviated scale of IQ (WASI): Current IQ | X | X | X | X | ||
MATRICS | X | X | X | X | ||
Biomarkers | Blood sample for biomarkers | X | X | X | X | |
Neuro-imaging3 | Magnetic resonance spectroscopy (MRS) | X | X | X |
1Shortened version to note for changes in work, study, living arrangements
2Telephone safety check
3Only participants who are in the Melbourne arm and provide informed consent for the imaging component will be administered these additional assessments