Outline of what participating in CEQUEL involves for people with bipolar disorder

The stages of the trial are shown on a flow chart and outlined below.

If you take part in the trial you will continue to see your psychiatrist for routine appointments as before and he/she will send brief information about your progress to the CEQUEL Office. In addition to this you will be asked to complete two self-report questionnaires each week giving details of any depressive and manic symptoms and to complete questionnaires on your Quality of Life and your need for additional health and social care services every four weeks.

Procedures to be completed in clinic with your psychiatrist

1. Consent to take part

Your psychiatrist (possibly assisted by members of the research team) will provide you with information (written and verbal) about the trial and answer any questions that you have. He/she will also ask you some questions to check that you are eligible for the trial. If you are eligible for the trial and are willing to take part your psychiatrist will ask you to sign a Consent Form.

2. Entry into the run-in phase

This will usually be arranged during an extended outpatient appointment. Your psychiatrist will:

complete forms (either on paper or on the internet) which give your name and contact details and brief information about your illness. These forms will be sent to the CEQUEL Office
either take a blood sample or provide you with sample tubes and packaging and ask you to go to your GP or local hospital to have a sample taken and sent to the CEQUEL Office
tell you about the self-report questionnaires and ask you whether you would prefer to complete them using mobile phone text-messages, web-based forms or on paper (see below)
prescribe quetiapine or write to your GP to arrange for him/her to prescribe the drug. If you are not already taking quetiapine, your psychiatrist may recommend routine pre-treatment tests. (If you normally pay prescription charges you will be asked to pay the charge for quetiapine but you will not have to pay for the allocated trial treatments i.e. lamotrigine/placebo and folic acid/placebo)
if appropriate (link to appropriate FAQ), your psychiatrist will advise you about stopping other medicines that you have been taking
make an appointment to see you in 7-14 days to discuss randomisation

3. Randomisation appointment

At this appointment your psychiatrist will ask whether you are tolerating quetiapine and ask you to complete self-report mood scales to check that you are eligible for the randomised phase. If you are eligible and willing to continue into the randomised phase your psychiatrist will:

complete forms (either on paper or on the internet) to arrange random allocation of lamotrigine or placebo and of folic acid or placebo
prescribe lamotrigine/placebo and folic acid/placebo. Your allocated medicines will be posted to you free of charge. They will be sent (recorded delivery) to your home which means that someone at that address will need to sign for them. If this is not convenient, you can ask for them to be sent to an alternative address. (See below for more information about posting trial medicines).

4. First follow-up appointment – 12 weeks after randomisation

At this appointment your psychiatrist will:

discuss your progress with you and send brief details to the CEQUEL Office
either take a blood sample or provide you with sample tubes and packaging and ask you to go to your GP or local hospital to have a sample taken and sent to the CEQUEL Office.

5. Final follow-up appointment – 12 months after randomisation