Time points at which different outcomes will be assessed
| Visit number | Baseline | Follow-up | ||||
| 1. | 2. Pilot trial 3 month data collection | 3. 6 month follow-up | 4. 12 month follow-up | 5. 24 month follow-up | 6. Qualitative evaluation | |
| Informed consent | X | X | ||||
| Eligibility determination | X | |||||
| Protocol assessments | A-I, L-O, Q, R | K | C-G, I-O, Q, R | C-O,Q, R | C-R | Indicative topic guide with sample of participants and psychiatrists |
| Randomisation | X | |||||
| IMP administration | X | X | X | X | X | |
| Adverse events review | X | X | X | X | X | |
| Medical notes review for prescribing information and fidelity to intervention protocols | X | X | X | X | X | |
| Concomitant medication review | X | X | X | X | X | |
A, Demographic information (selected sections including weight and use of illicit drugs and alcohol); B, Diagnosis (established from clinical records); C, Social Functioning Scale (SFS); D, Positive and Negative Syndrome Scale (PANSS); E, Glasgow Antipsychotic Side-effect Scale (GASS); F, Client Satisfaction Questionnaire (CSQ-8); G, Manchester Short Assessment of quality of life (MANSA); H, Neuropsychological function tests; I, Medication Adherence Rating Scale (MARS-5); J, Relapse questionnaire; K, Serious Adverse Events; L, EQ-5D-5L; M, ICECAP-A; N, Client Service Receipt Inventory; O, Work Productivity and Activity Questionnaire; P, Schedule for economic data from patient records; Q, Questionnaire about the Process of Recovery (QPR); R, Arizona Sexual Experiences Scale (ASEX).
IMP, Investigational Medicinal Product.