Table 1

Time points at which different outcomes will be assessed

Visit numberBaselineFollow-up
1.2. Pilot trial 3 month data collection3. 6 month follow-up4. 12 month follow-up5. 24 month follow-up6. Qualitative evaluation
Informed consentXX
Eligibility determinationX
Protocol assessmentsA-I, L-O, Q, RKC-G, I-O, Q, RC-O,Q, RC-RIndicative topic guide with sample of participants and psychiatrists
RandomisationX
IMP administrationXXXXX
Adverse events reviewXXXXX
Medical notes review for prescribing information and fidelity to intervention protocolsXXXXX
Concomitant medication reviewXXXXX
  • 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.