E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Psychosis is a medical term used to describe hearing or seeing things that do not exist, or believing things that other people do not. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10001022 |
E.1.2 | Term | Acute psychosis |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the feasibility (including recruitment, retention, adherence, acceptability) of the addition of antidepressant medication to antipsychotic treatment in patients with early psychotic illness to prevent relapse. |
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E.2.2 | Secondary objectives of the trial |
To assess symptoms displayed by participants over the course of the intervention in the treatment and placebo groups. Measurements of such symptoms would be secondary outcomes in a larger trial and would be expected to predict future relapse rates. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Within three years of diagnosis of a psychotic illness; Aged 18-65.
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E.4 | Principal exclusion criteria |
Lacking capacity to consent to treatment and trial procedures (as assessed by the research nurse); Acute psychotic episode at time of recruitment (PANSS rating >80 or who in the view of their treating team are too unwell to take part); Currently prescribed antidepressant medication; Contraindications to sertraline treatment e.g. concurrent contraindicated medications such as Monoamine Oxidase Inhibitors (MOAIs), pimozide or any other serotonergic drugs (e.g. triptans), or opiates; Recurrent thrombotic illness; Previous adverse reaction to sertraline; Poorly controlled epilepsy; Dependent on alcohol or other illicit substances (as per ICD11 definitions); If psychosis is considered by the responsible clinician to be clearly substance induced AND there is evidence that the psychosis has resolved within one month of abstinence from the substance; Any significant risk to themselves or others; Confirmed pregnancy.
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E.5 End points |
E.5.1 | Primary end point(s) |
These will assess feasibility of the intervention and trial procedures. We will not assess relapse rates but will assess: 1. Recruitment into the trial 2. Retention over a 24-week treatment period 3. Adherence to antidepressant medication 4. Acceptability of the intervention 5. Maintenance of blinding (participants, clinical staff, outcome assessors and the trial statistician will be blind to treatment allocation) 6. Feasibility of collecting outcome data in this population including health related quality of life using the EQ-5D 7. Serious adverse events (including comparative rates between trial arms) 8. Impact of wider contextual factors including health service use on trial recruitment, delivery, uptake and adherence. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluations will take place over the entire length of the trial. |
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E.5.2 | Secondary end point(s) |
Symptomatic outcomes over the course of the intervention in the treatment and placebo groups. These measures would be secondary outcomes in a larger trial and would be expected to predict future relapse rates. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluations will take place over the entire length of the trial. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be considered as the date on which the last participant has completed their last follow up assessment or when the final clinican focus groups are held - which ever comes last. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 31 |