- For Patient Participants
Do I have to provide a DNA sample to take part?
Yes; you must provide either a blood, saliva or buccal (cheek) swab sample for genetic testing.
Do patient participants have to have a diagnosis, or can they just be taking antipsychotics?
Patients should fulfil both requirements. This is because a patient without a psychosis diagnosis may be on a low dose of antipsychotics and or may use them on and off which may lead to a sample with too much variation.
Do patients have to be taking antipsychotics or can they be taking antidepressants?
We currently prefer to recruit patients who are on antipsychotics because the funding we have for the study was given for patients that take antipsychotics. If there was a big demand from patients who take antidepressants, then we can consider recruiting them.
How long can patients expect to wait for their results?
Regarding the genetic report we cannot give a time frame on when patients will receive their genetic results. This is a new intervention within the NHS and COVID has had a massive impact on how labs are operating. The lab we are currently working with processes samples in batches. Patients can expect to receive their genetic results a minimum of two months after the baseline assessment.
- For Clinician Participants
What are the clinicians consenting to?
Allowing the local site to access their caseload, approaching, and discussing the study with eligible patients and discussing the results of the genetic test with the patient.
How will clinicians receive the results?
The clinician will be sent the genetic report. The genetic report will be in PDF format. The genetic report will operate on a traffic light system with recommendations for prescribing and dosing medication. Where EMC provides guidance, this has been prioritised. For more antipsychotics, the guidance is based on DPWG guidelines or FDA approved labels and FDA table of Pharmacogenetic associations.
What enzymes are we profiling?
CYP2D6 and CYP219 Enzymes. These enzymes have guidelines and are evidence based.
Are you looking at current medication only or pre-emptive pharmacogenomics?
We’re looking at pre-emptive medication. Results will be included in the patient’s electronic health care records, and this can be used to guide medication in the future.
- For Sites
What happens if a patient is recruited inpatient, e.g. a ward, and then discharged to community services before the intervention (genetic report) has been delivered?
The original clinician consented into the study receives the report. If that clinician is unable to contact the patient, then the community clinician can be contacted and consented into the study to deliver the genetic report. The GP can be included as the clinician. If the new consultant is disinterested, then the genetic report can be added to the patient’s electronic health care records and other clinicians e.g., a pharmacist can provide advice and guidance.
What is the optimal way of posting back the saliva samples?
Ultimately the site decides how to send back the saliva samples. We ask that you place the tube back in the plastic container (this can withstand being crushed), place in an envelope (this can be padded or not) with an absorbent pad and a UN3733 diagnostic specimen label. Label the envelope with the UCL address (see below) and a return address.
Where do we send the saliva kit to?
Send the sample to:
University College London
Pharmacogenetics in Mental Health
Division of Psychiatry
University College London
Maple House 6th Floor, Wing A
149 Tottenham Court Road,
London, W1T 7NF
How are the samples stored?
Blood samples will be stored in the freezer. Saliva samples can be stored at room temperature.
Do you prefer blood or saliva samples?
We are happy to accept blood or saliva samples. We can easily extract DNA from blood samples in the lab.
Who can obtain a blood sample?
We have noticed that saliva samples have been easier for sites to obtain, but on occasions when this hasn’t been possible there is always the option of bloods. Bloods will have to be taken by a trained member of staff within the local team.
How is blood stored?
In a 4 degree fridge for up to a week or in a - 20 degrees standard freezer indefinitely. This is convenient for sending batches. If there are no low temperature facilities i.e. fridge at 4 degrees or -20 degree freezer, samples can be stored at room temperature for up to three days, but the sending of the samples should be expedited and not delayed for batch accumulation.
When would you like the blood samples?
We would prefer the blood samples the day of collection. We understand this is not always possible the samples must be stored - 20 degrees indefinitely or at room temperature for no more than three days before being sent
How do we send the blood samples?
If you do not have an internal courier for sample delivery, we can give you several options of couriers that can be booked for the same day. These are only suggestions based on couriers we have used in the past and we do not have any business affiliations with them.
What blood tube should we use?
The Lavender top (example: BD Vacutainer example: BD Vacutainer™ Plastic K2EDTA Tube with Lavender Hemogard closure).
What do the blood tubes need to be transported in?
We prefer them to be sent in the CAT B Bags, these bags come with an absorbent pad and sealable strip.
Where do we ship the blood samples to? Is it the same address as the saliva samples?
No, blood is shipped directly to our lab colleague Marius Cotic at:
UCL Great Ormond Street Institute of Child Health
Zayed Centre for Research into Rare Disease in Children
20 Guilford Street,
London WC1N 1DZ