OPEN RESEARCH STUDY
We are working with the Birmingham University to find out if an antidepressant medication (Sertraline) can help to prevent depression in people who have experienced first episode psychosis.
Diagnosis of first episode psychosis (FEP)
Within 12 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
Male and females aged 18-65 years.
Currently prescribed antipsychotic medication at a stable dose
Female participants must be willing to use one form of highly effective contraception.
Current moderate or severe depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score >7
Currently prescribed antidepressant medication (or within 2 weeks of stopping if previously prescribed a monoamine oxidase inhibitor)
Previous history of mania
Contraindications to SSRI antidepressant treatment: e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy or planning to become pregnant (although risk in pregnancy is low), prescribed pimozide. (See sertraline SmPC)
Serious medical or neurological illness (as identified by a medically qualified doctor)
Hypersensitivity to the active substance or any of the excipients or placebo
Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)
Patient with any other systemic dysfunction (e.g. gastrointestinal, renal, respiratory, cardiovascular, neurological or psychiatric) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial
Electrocardiogram (ECG): QTc interval >450 ms recorded in the last 12 months
Aged below 18 years
Aged over 65 years
Female participants that do not agree to follow the protocol contraception requirements
What is involved?
Sign the main study consent form
Take a medication (either sertraline or placebo with no active ingredient) every day for the next 6 months
Complete assessments 8 times in total, which involves answering a series of questions in the form of interviews and questionnaires
Have a blood sample taken
You won't be able to choose which medication you receive. Instead, you will be randomly put in either sertraline or placebo group.
Interested in taking part?
Email the team to find out more: email@example.com