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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Mark
Pearce
ADEPP@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
First Episode Psychosis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
First episode of psychosis (FEP) typically begins in the late teens or early 20s and is diagnosed by the presence of hallucinations and delusions. Medication and cognitive behavioural therapy help to treat these symptoms, but young people struggle to return to previous social and work roles, have suicidal thoughts and are at high risk of relapse. These are related to depression experienced after FEP. 40% of people who have experienced FEP will become depressed. Antidepressant medication is effective for treating depression in established schizophrenia, and robust evidence suggests that using antidepressants in young people over the age of 18 along with medication for psychosis is safe. However, researchers want to know whether antidepressant medication can reduce the risk of depression happening at all after FEP, and whether preventing depression can improve recovery and reduce relapse. This study aims to find out if an antidepressant medication (sertraline) can help to prevent depression in people who have experienced a psychotic episode for the first time.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37803384/ (added 10/10/2023)
You can take part if:
Current inclusion criteria as of 20/03/2023:
1. Diagnosis of first-episode psychosis (FEP)
2. Within 12 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team)
3. Positive and Negative Syndrome Scale (PANSS) individual positive item scores all ≤4
4. Sufficiently recovered from acute psychotic episode with capacity to consent
5. Males and females aged 18-65 years
6. Currently prescribed antipsychotic medication at stable dose.
7. Female participants must be willing to use one form of highly effectiv
You may not be able to take part if:
Current exclusion criteria as of 20/03/2023:
1. Current moderate or severe depression (as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of > 7)2. Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidase Inhibitor)3. Previous history of mania4. 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)5. Serious medical or neurological illness (as identified by the treating consultant psychiatrist)6. Hypersensitivity to the active substance or any of the excipients or placebo7. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)8. 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 jeopardize the safety of the patient by taking part in the trial9. Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months10. Aged below 18 years11. Aged over 65 years12. Female participants that do not agree to follow the protocol contraception requirements
_____
Previous exclusion criteria:
1. Current moderate or severe depression (as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of > 7)2. Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidase Inhibitor)3. Previous history of mania4. 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)5. Serious medical or neurological illness (as identified by the treating consultant psychiatrist)6. Hypersensitivity to the active substance or any of the excipients or placebo7. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)8. 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 jeopardize the safety of the patient by taking part in the trial9. Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months10. Aged below 18 years11. Aged over 35 years12. Female participants that do not agree to follow the protocol contraception requirements
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Mark
Pearce
ADEPP@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127700.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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