Psychosis MedDRA version: 21.1 Level: PT Classification code 10001022 Term: Acute psychosis System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Sertraline
Product Name: Sertraline
Pharmaceutical Form: Tablet
INN or Proposed INN: sertraline hydrochloride
CAS Number: 79617-96-2
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Within three years of diagnosis of a psychotic illness; Aged 18-65. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: Evaluations will take place over the entire length of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Evaluations will take place over the entire length of the trial. | — |
Countries
United Kingdom
Contacts
Public ContactTrial Manager
Centre for Trials Research, Cardiff University
Outcome results
None listed