Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Consenting participants are randomly allocated to one of two groups.
Control group: Participants continue to receive antipsychotic treatment at the original dose.
Intervention group: Participants ta
Sponsors
University College London
North East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other non-affective psychosis 3. More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year 4. Taking antipsychotic medication
Exclusion criteria
Exclusion criteria: 1. Participant lacks capacity to consent to the trial 2. Participant has insufficient command of spoken English to understand trial procedures 3. Participant subject to a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication 4. Clinician considers there will be a serious risk of harm to self or others 5. Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month 6. Females who have a confirmed pregnancy 7. Females who are breast-feeding 8. Involvement in another IMP trial 9. No contraindications to continuing on antipsychotic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social functioning is measured by the Social Functioning Scale at baseline, 6, 12 and 24 months Added 14/09/2022: Also measured between 48-84 months from randomisation into the original trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms are measured by the Positive and Negative Syndrome Scale (PANSS) at baseline, 6, 12 and 24 months 2. Side effects as measured by the Modified Glasgow Antipsychotics Side-effects Scale (GASS) at baseline, 6, 12, and 24 months 3. Patient satisfaction as measured by the Client Satisfaction Questionnaire (CSQ 8) at baseline, 6, 12 and 24 months 4. Subjective quality of life as measured by the Manchester Short Assessment of quality of life (MANSA) at baseline, 6, 12 and 24 months 5. Neuropsychological function tests at baseline, 12 and 24 months 6. Medication adherence as measured by the Medication Adherence Rating Scale (MARS-5) at baseline, 6, 12 and 24 months 7. Relapse as measured by the relapse assessment schedule questionnaire at 6, 12 and 24 months 8. Health state as measured by the EQ-5D-5L at baseline, 6, 12 and 24 months 9. Wellbeing as measured by the ICECAP-A at baseline, 6, 12 and 24 months 10. Cost of health and social care as measured by the Client Service Receipt Inventory at baseline, 6, 12 and 24 months 11. Ability to work as measured by the Work Productivity and Activity Questionnaire at baseline, 6, 12 and 24 months 12. Economic data collected from patient records at baseline 12 and 24 months 13. Recovery as measured by the Questionnaire about the Process of Recovery (QPR) at baseline, 6, 12 and 24 months 14. Sexual experiences as measured by the Arizona Sexual Experiences Scale (ASEX) at baseline, 6, 12 and 24 months Added 14/09/2022: All outcome measures except the social cognition battery will also be measured between 48-84 months from randomisation into the original trial | — |
Countries
England, United Kingdom
Outcome results
None listed