Current Research All studies are approved by an NHS Research Ethics Committee and by the Trust.

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1 Current Research Please see the list below of active research studies which are taking place at Greater Manchester West Mental Health NHS Foundation Trust: Research is needed to improve and develop mental health services. It is your right to know about the research that is happening at the Trust and have the opportunity to take part if you wish. If you want to find out more about any of the studies listed below, please contact the research team or the Senior Clinical Studies Officer, Steve Lankshear All studies are approved by an NHS Research Ethics Committee and by the Trust. Schizophreni a/ Psychosis In contact with mental health services Aged 18+ In contact with mental health services A study to investigate the role of attention in psychotic symptoms and the feasibility and acceptability of using attention training as a strategy for individuals with psychosis (IACT) Researcher: contact Dr Sophie Parker Sophie.parker@gmw.nhs.uk A pilot study of a randomised controlled trial of antipsychotic medication in comparison to cognitive behaviour therapy and a combined treatment in adults with psychosis (COMPARE) A brief, MCT informed attention training intervention for individuals with psychosis. Two arm, randomised, pilot study comparing attention training (ATT) with treatment as usual (TAU). Participants in the ATT group will undergo attention training and practice using audio CV once per day inbetween sessions ( 10 for 3 assessment interviews). Clinical trial pilot study to compare CBT with Antipsychotics and a combination of the two in adults with psychosis. Participants will be randomized into 3 treatment groups. Symptoms, functioning, quality of life and wellbeing, side effects and acceptability will be measured. Qualitative

2 interviews with participants to examine their views of the different treatments. ( 50 in total for 5 appointments over 1 year) Schizophreni a/ Psychosis Within first 3 years of symptom onset. Aged Neuroimaging a single dose of modafinil on brain activity in psychosis (RCT) (Ref:796) Sally Preston ( ) sally.preston@manchester.ac. uk Cognitive impairment associated with schizophrenia (CIAS) i.e. problems with memory, attention and planning, are almost universal in patients with Schizophrenia. Research suggests that modafinil can reduce CIAS. Study aims to understand how cognition enhancing drugs modify abnormalities in brain networks functioning; the effects of modafinil on both behavioural tests and cognition-related brain networks in volunteers with schizophrenia will be tested. Participants will undergo a variety of assessments including MRI (Max of 200) Within first 3 years of symptom onset. Aged The Benefits of Minocycline On Negative Symptoms in Schizophrenia (BeneMin) (RCT) (REF:727) Kelly Byrne ( ) kelly.byrne@manchester.ac.uk Study looking at whether taking minocycline in addition to usual anti-psychotic medication can help improve negative symptoms. Participants will be required to take minocycline or placebo in addition to standard treatment. Participants will also undergo variety of assessments, 2 MRI scans & have saliva & blood samples taken. ( 60)

3 Taking or tried clozapine & has current symptoms Aged 14-35, less than 6 weeks of antipsychotic medication Aged Focusing on Clozapine Unresponsive Symptoms (FOCUS) (RCT) (REF:758) ( / ) sarah.tully@gmw.nhs.uk Identifying the Prevalence of Antibodies to Neuronal Membrane Targets in first episode Psychosis (PPIP) (REF:775) ( ) steve.lankshear@gmw.nhs.uk Belief & Psychosis: An Interview & Diary Study (REF:782) ( ) chrisdjtaylor@manchester.ac.u k Study looking at the effectiveness of CBT for individuals with schizophrenia. This is open to referrers of individuals who take clozapine and still experience symptoms or who have discontinued clozapine in the past 24 months. Participants will have a 50% chance of receiving 30 sessions of CBT and a 50% chance of receiving treatment as usual alongside assessments.( non cash vouchers) Study looking at the prevalence of anti-bodies in a larger cohort of patients in first prevalence psychosis. Participants will be required to give 1 sample of blood & undergo 1 x 60 mins clinical history and rating scales. ( 10) Study looking at beliefs/schemas and psychotic experiences. Study involves: Part 1: 1 x 90 min Interview, Part 2: 6 days of 10 daily diary inputs into a PDA + 1 x 90 min interview. (Part 1: 10, Part 2: 20).

4 OR Depression Aged between Aged between Taking Or Not Taking antipsychotic s Not on Anti- Depressants CNS Inflammation in Major Depressive Disorder and Schizophrenia measured invivo using Positron Emission Tomography (CNS) (REF:631) ( / ) Sophie.holmes@postgrad.man chester.ac.uk Participants take part in screening interview, PET & MRI scan to investigate potential basis of these conditions. Participants will be required to have a screening interview, a blood sample, PET scan & MRI scan.( 40) At high risk of developing psychosis Meet criteria for Early Intervention Currently stable In touch with Mental Health Services and have a case manager A Clinical Trial of Meta- Cognitive Therapy for Individuals at High Risk of Developing Psychosis (ref 811) Researcher: contact Dr Sophie Parker Sophie.parker@gmw.nhs.uk Study aims to examine effectiveness of metacognitive therapy (MCT) for patients at high risk of developing psychosis, in reducing the risk of their symptoms progressing to psychotic illness. Patients will undergo 12 1 hour sessions of MCT by a trained psychologist, within working hours at a venue that is suitable for the participant. (3 payments of 10 to be made to participants at beginning, end and 6-month follow-up of study)

5 Dementia. Aged Efficacy and safety of 3 doses of S38093 (2, 5 and 20mg/day) versus placebo in coadministration with donepezil (10mg/day) in patients with moderate Alzheimer's Disease. A 24 week international, multicentre, randomised, double-blind, placebocontrolled phase IIb study. (REF:795P) Syeda Khatun ( ) syeda.khatun@dendron.org.uk Aims to investigate efficacy and safety of a new drug in Alzheimer s disease, in combination with standard treatment, donepezil. Participants will be put into four groups; each group will be given a different treatment and the results of all the groups will be compared. They will be given a supply of study medication (S38093) that will contain one of the four following doses: 2mg, 5 mg, 10mg or a placebo/dummy pill. This will be taken in addition to the usual 10mg daily dose of donepezil. The participants will also undertake a number of test include ECG, blood and urine samples, MRI scans and questionnaires over 6 hospital visits and 2 telephone calls. Carer of a person with mild dementia Changes in the motivation and performance of activities of daily living in people with memory problems: Application and validation of a new tool. (Ref: 826) Clarissa Giebel Clarissa.giebel@manchester.ac.uk The primary objective of this study is to validate the newly developed 'Changes to the Initiative and Performance of Everyday Activities in Dementia Questionnaire' (CIPEAD) in mild dementia. 12-page questionnaire to be completed by carers (time taken minutes) first 10 participants will complete the questionnaire with the investigator, to gauge the user-friendliness of the questionnaire.

6 Personality Disorder Experience of receiving care from MH settings (Community or Forensic) Personal Recovery in Relation to Personality Disorderseeking to understand service user experiences in community and forensic settings (REF: 809) Andrew Shepherd The study will look at service users experience of contact with MH services, hopes for future recovery, or change in sense of self, personal identity, role of social relationships, and will review outcome measures used in PD. Service users will undergo 60 minute qualitative interviews in community, hospital, prison, probation service, or secure hospital settings. They will be asked to attend Focus Groups to talk through the findings (90 mins). Involvement with violent, aggressive events requiring staff intervention, in an inpatient setting Service user with inpatient admission in last year/ Relative of service user/ Frontline staff or PMVA trainer (minimum 6 mnths experience) Exploring mental health staff s use of de-escalation techniques to manage violence and aggression (REF: 812) Owen Price Owen.price@manchester.ac.uk The study looks at deescalation techniques from 4 perspectives: service users, clinical staff, carers, and trainers, in order to identify barriers to and facilitators of optimal use of de-escalation techniques and gain perspectives on what staff training is needed. Participants will undergo semi-structured individual interviews and general information questionnaires. Attended the Recovery Academy, or planning to attend Service users, health professionals, family members or carers who have attended the Recovery Academy, or those who have enrolled for the first time. Questionnaires and qualitative interviews to explore whether the GMW Recovery Academy can have a positive impact on service users, health professionals and family members or carers who attend courses. (REF: 813) Researcher contact: Paul French Paul.french@gmw.nhs.uk Self-report questionnaires prior to first course (baseline) and at 3, 6, and 12 month follow up points, for those who are attending for the first time. Qualitative focus groups at 3 month follow up point for those who have already attended.

7 For more information on any of the above studies please contact the research team or Steve Lankshear (Senior Clinical Studies Officer) on