Patients with First Episode Psychosis.
Conditions
Interventions
Product Name: Sertraline
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sertraline hydrochloride
CAS Number: 79559-97-0
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of first-episode psychosis (FEP). • Within 3 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team). • Positive and Negative Syndrome Scale (PANSS) individual positive item scores all = 4. • Sufficiently recovered from acute psychotic episode with capacity to consent. • Aged 18-35 years. • Currently prescribed antipsychotic medication at stable dose. 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 508 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Current moderate or severe depression (as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of >7). • Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidaise Inhibitor) • Previous history of mania. • Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide). • Serious medical or neurological illness (as identified by the treating consultant psychiatrist). • Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months. • Aged below 18 years • Aged over 35 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main trial's primary objective is to assess the effectiveness and cost effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis. The primary outcome will be the number of new cases of depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of greater than 5 and confirmed by Mini International Neuropsychiatric Interview (MINI) in each treatment arm over the 6-month intervention phase. A feasibility pilot study is incorporated into this study to assess acceptability of the trial 12 months into recruitment, using clear traffic light stop-go criteria. The percentage of eligible patients recruited, percentage of usable data of the first 50 recruits, retention rate and adherence rate will be assessed. ;Secondary Objective: Secondary Outcomes: 1. Assess the presence and change in symptoms of psychosis using the Positive and Negative Syndrome Scale (PANSS; the established 30 item semi-structured interview). It has both total score and subscales for positive, negative and general symptoms. 2. Assess the presence of suicidal ideation and attempts in lifetime ever and preceding 12 months, together with current suicidal ideation and beliefs about future risk, using the Suicidal Behaviours Questionnaire-Revised (SBQ-R; a 4 item validated tool). It has established linear total and cut off scores to identify those with and without the reported risk. 3. Assess trait and current (state) anxiety using the State-Trait Anxiety Inventory (STAI; commonly used 20 item self-report scale). 4. Assess generalised anxiety using the General Anxiety Disorder (GAD7; a brief 7 item anxiety scale). 5. Relapse of psychosis: as defined by a hospital admission or acute community care provided by Home Treatment / Crisis Interventi;Primary end point(s): The number of new cases of depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of gre | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 and 12 months post randomisation.;Secondary end point(s): Secondary Outcomes: 1. Assess the presence and change in symptoms of psychosis using the Positive and Negative Syndrome Scale (PANSS; the established 30 item semi-structured interview). It has both total score and subscales for positive, negative and general symptoms. 2. Assess the presence of suicidal ideation and attempts in lifetime ever and preceding 12 months, together with current suicidal ideation and beliefs about future risk, using the Suicidal Behaviours Questionnaire-Revised (SBQ-R; a 4 item validated tool). It has established linear total and cut off scores to identify those with and without the reported risk. 3. Assess trait and current (state) anxiety using the State-Trait Anxiety Inventory (STAI; commonly used 20 item self-report scale). 4. Assess generalised anxiety using the General Anxiety Disorder (GAD7; a brief 7 item anxiety scale). 5. Relapse of psychosis: as defined by a hospital admission or acute community care provided by Home Treatment/ Crisis Intervention team. 6. Functioning: assess the overall impact of psychological disturbance on functioning. Given the complexity factors that may impact on functioning in emerging psychosis, the Social and Occupational Functioning Scale (SOFAS) and the Functional Remission of General Schizophrenia (FROGS) will both be rated. 7. Quality of life: EQ-5D and ICECAP-A. EQ-5D is a 5 item health related quality of life assessment scale with well established reliability and population norms and the Investigating Choice Experiments Capability Measure for Adults (ICECAP-A), a more detailed measure of heath individual capability, used to supplement economic evaluation as the benefits of health and social care are not confined only to patients themselves. 8. Side effects: Barnes Akathisia Scale (BARS), Antipsychotic non-neurological side effects rating scale-compiled (ANNSERS-c) and Simpson Angus Scale | — |
Countries
United Kingdom
Contacts
Public ContactBirmingham Clinical Trials Unit
University of Birmingham
Outcome results
None listed