Treating Anxiety to PrevEnt Relapse in Psychosis (TAPERS): a feasibility trial
- Conditions
- PsychosisMedDRA version: 21.1Level: PTClassification code 10001022Term: Acute psychosisSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-001408-39-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method