Introduction



926333147378SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA).A randomised controlled trial.00SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA).A randomised controlled trial.STRATAMedication Instruction Booklet How to take your study medication Sponsor: [The University of Bristol (UK) / The University of Western Australia] Trial website: bristol.ac.uk/strataLocal study team phone number: [Insert local study phone number] Local study team address: [Insert Local study address]Central study team email (UK): strata-rct@bristol.ac.ukCentral study team phone number (UK): [CENTRAL PHONE NUMBER]left279077This study is funded by the National Institute for Health Research (NIHR) HTA Programme (Ref: 127337).The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.The authors and University of Western Australia acknowledge funding from the National Health and Medical Research Council (Project Grant 1171206). The contents of the published material/website are solely the responsibility of the authors and do not reflect the views of NHMRC.00This study is funded by the National Institute for Health Research (NIHR) HTA Programme (Ref: 127337).The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.The authors and University of Western Australia acknowledge funding from the National Health and Medical Research Council (Project Grant 1171206). The contents of the published material/website are solely the responsibility of the authors and do not reflect the views of NHMRC.37209808074217004333431116673500Introduction This booklet tells you about the study medication and how to take it. If you are unsure about any of the information in this booklet or have any questions related to the STRATA study, please contact your local study team (or the central study team) using the contact details provided on the front page. What is the medication?The medication will be in the form of white capsules; see example picture below. The capsules will either contain sertraline (the active drug) or a placebo (inactive drug). Please note that the capsules may contain gelatine which may not be suitable for vegetarians and vegans.Neither you, those involved in looking after you, nor the study team will know whether you have been allocated sertraline or placebo capsules. How will I receive the medication? [UK option] The medication will be posted to your specified address, such as your home, by signed for delivery. You will receive your medication shortly after you join the study (“week 0”), then around week 4, week 8, week 12, and then at intervals depending upon your dose, for the remainder of the study (up to 52 weeks after you join).In some cases, it may be possible to send the medication to your GP (Doctor’s) Practice, or local pharmacy if preferred. Where relevant, this option can be explored with the study team, but cannot be guaranteed.[Australia option] The medication will be available for collection directly from the local hospital pharmacy. Your medication will be available shortly after you join the study (“week 0”), then around week 4, week 8, week 12, and then at intervals depending upon your dose, for the remainder of the study (up to 52 weeks after you join).In some cases, it may be possible to send the medication to your (Doctor’s) Practice, or delivered to your home if preferred. Where relevant, this option can be explored with the study team, but cannot be guaranteed. How do I take the medication?The medication capsules can be taken with or without food. The medication capsules must be swallowed whole. You should take the capsule(s) once daily, either in the morning or the evening. Taking medication at the same time everyday makes it easier to remember.Dose strengthsYou will first receive a starter pack of 25mg capsules of medication. You will be asked to take one capsule of the 25mg medication each day for 2 weeks, followed by two capsules of the 25mg medication each day. After around 6 weeks since starting the study, you will then be sent a new supply of 50mg capsules of the medication. The dose can then be gradually increased up to a maximum of 200mg (four capsules of 50mg) daily. We will discuss the dose of the medication with you at regular intervals as described below to find the right dose to suit you. This will depend upon how you respond to the medication and whether you have any side effects. In total, you will be asked to take the study medication for up to 52 weeks after you join, although you will have the option of stopping the medication at any time. If you stopped the medication, we would help you with this.How is the dose of medication that I should take decided?Around 1 to 2, 4, 8, 12, and 36 weeks after you joined the study, a member of the study team will contact you to see how you are responding to the medication. They will ask you some brief questions about whether the medication is helping you and whether you are having any side effects, and answer any questions you may have. They will also discuss which strength of medication you may be offered next.Decisions about changes in the dose will be taken by the clinician prescribing you the study medication, taking into account your wishes and responses to the questions during the safety checks. If you experience undesirable side effects, you may be advised to stay on the current dose, or go down to a lower dose. What happens when I reach the most suitable dose, or the maximum dose allowed?Once you have reached the dose most suitable for you or the maximum dose allowed, you will be asked to continue taking this dose of medication until the end of the study. However, you may decide to stop the medication earlier for any reason. What happens when the study treatment medication stops?At the end of the study treatment period (52 weeks) the study team will provide you with further instructions about how to safely reduce and stop the medication. We will do the same if you decide to stop taking the treatment before 52 weeks; see Section 8 for more information. What if I accidentally take more capsules than prescribed? If you accidentally take too many capsules, contact your GP (doctor, or equivalent healthcare professional) at once or go to the nearest hospital emergency department. Always take the labelled medicine package with you, whether there is any medication left or not. Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartrate, shaking, agitation, dizziness and in rare cases unconsciousness.What if I forget to take the medication? The medication can be taken at a time of day that is convenient for you. You should try to take the medication at the same time of day every day (for example, in the morning with breakfast), but if you do not take it at your usual time, you should take it as soon as you remember on the same day.If you forget to take the medication on any one day, please make a note of this, and take the usual amount of medication you are taking the following day. Please do not take two days’ worth of medication on one day.If you forget to take the medication for 2 or more days, please contact us so that we can arrange for the prescriber to advise you. This advice may involve resuming the current dose or starting back on a lower dose.What if I want to stop taking the medication? Please contact the study team if you would like to stop taking the medication at any point; see contact details on the front page. You will be advised how to reduce and stop taking the medication safely. This is important because if you suddenly stop taking this medicine, particularly if you are on a high dose, you may experience discontinuation effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick, and shaking. How should I store the medication?Store at room temperature (15-300C). Keep this medicine out of the reach and sight of children. Do not use this medicine after the expiry date. Do not use this medicine if you notice visible signs of deterioration. What side effects can the medication cause?Like all medicines, sertraline can result in side effects for some people, but it is important to remember that not everybody encounters them.The side effects depend on the dose and often disappear or lessen with continued treatment. Nausea is the most common side effect. Other common (happen in more than 1 in 100 people) known side effects of sertraline are:DizzinessDry mouthSleep problemsDrowsiness/fatigueHeadacheDiarrhoeaSexual problems (including ejaculation failure, erection problems, reduction in sex drive).This is not an exhaustive list. If you require further details about the possible side effects of sertraline, they can be found in the Summary of Product Characteristics (SmPC) leaflet available on the STRATA website. You can also talk to the STRATA team if you have any queries or concerns. Some people find their anxiety gets worse during the first few weeks of treatment, although this usually wears off after a few weeks. Some people may experience new suicidal thoughts after starting the medication. We suggest that you tell your family and/or carer about these possible side effects. We will monitor any side effects that you may experience carefully.What should I do if I experience any of the listed side effects?You do not have to wait for the next study point of contact/appointment before telling us about side effects. You can contact a member of the study team as needed, using the contact details on the front page. Depending on how severe the side effect is, we may suggest: A discussion with the clinician prescribing you the study medication.Continuing with the medication and seeing if the symptoms resolve.Seeking treatment for the side effect e.g. from your doctor/GP.That you take a lower dose. That you stop the medication completely. If a symptom makes you feel very unwell and/or is particularly troublesome (e.g. significant worsening of your anxiety, or new symptoms such as suicidal thoughts), you must seek medical help in the normal way (see below). The study team can ONLY advise you on what to do with the study medication. They cannot provide you with any other medical advice.[UK option] For example: via phoning 111, contacting your doctor (GP practice), or in an emergency phoning 999 or going to an Emergency Department (A&E). [Australia option] For example: via phoning health direct on 1800 022 222, or calling the Mental Health Emergency Response Line on 1300 555 788, or contacting your GP000. In an emergency you should phone the emergency services or attend an Emergency Department. Will the study medication affect other medication I take?When you joined the study, you were asked about your current health and other medications and/or remedies that you were taking. This was to ensure that none interfere with the study medication (i.e. either sertraline or placebo). Based on that information, it was considered safe for you to take part in this study and take the study medication. IMPORTANT: If your current health, medication, or use of other remedies changes while you are part of this study, you should let the study team know.You can continue taking your other medications as normal throughout the study. Your doctor (GP, or equivalent healthcare professional) can prescribe most other medications normally. However, you cannot be prescribed sertraline or other similar medications used for treating depression or anxiety at the same time. When you agreed to take part in this study, a member of the study team will have written to your doctor informing them that you are taking part in this study so they can consider this when prescribing any other medication to you. Returning unused study medicationWhen you finish taking the study medication (either at 52 weeks, or sooner if you decide to stop before), you will likely be asked to return any unused medication to a local pharmacy for them to safely destroy. Further details will be provided when applicable.Other advice If you were to need a general anaesthetic to undergo any operations, then it would be important to let the anaesthetist (the doctor who puts you to sleep for the operation) know that you are participating in this study.If you become pregnant while taking the study medication, then you should inform a member of the study team using the contact details on the front page. Diet. In general, you do not need to make any changes to your diet when taking the study medication. However, it is advisable to avoid grapefruit juice when taking this medication as it can slow down the metabolism of the medication. Driving and operating machinery. Studies have not shown any effect of sertraline on ‘psychomotor performance’. However, as some of the medication ingredients may impair mental and physical abilities to drive or operate machinery, caution is advised. Tips for remembering to take the medicationGeneral tipsKeep it visible, but out of reach of children, if applicable (e.g., on the bathroom shelf, kitchen worktop)Combine it with a daily task, such as making coffee or tooth brushingUse a pill box with days of the weekIf you take other medication, include this into that routine Using RemindersSet an alarm or a calendar alert on your phone with a label such as ‘take medication’ for the same time every dayPut a note on your bathroom mirror, or on a cupboard you use every morning (for example, when making a cup of tea)Use a medication reminder appAdditional information Summary of Product Characteristics (SmPC). Additional information about the medication sertraline, including ingredients, can be found in the supporting SmPC leaflet, that is available on the STRATA study website. ................
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