South London and Maudsley NHS Foundation Trust: FY1819 Q2 Performance in Initiating

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1 of First 17/YH/ /YH/ /LO/ /LO/ /WM/ /LO/ A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Second Generation Antipsychotics in Subjects With Stable Schizophrenia A Phase 2 Randomized, Investigator- Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia A feasibility study and pilot trial of a modified video-feedback intervention for children and foster carers to improve mental health outcomes of children with reactive attachment problems A feasibility study of Acceptance and Commitment Therapy for older people with treatment-resistant generalised anxiety disorder (FACTOID) A randomised controlled clinical trial of therapist-assisted online psychological therapies for post-traumatic stress disorder (STOP-PTSD) An investigation into social information processing in adolescents with eating disorders: Implications for theory and clinical practice 01/11/ /10/ /08/ /10/ /11/ /11/ /03/2018 Neither 01/11/ /10/ /11/ /10/ /11/ /10/ /02/2018 Neither 06/10/ /10/ /08/ /03/ /03/ /03/ /08/2018 Sponsor 18/07/ /11/ /09/ /12/ /12/ /12/ /01/2018 Sponsor 16/11/ /11/ /01/ /01/ /01/ /01/ /03/2018 NHS Provider 26/09/ /12/ /12/ /03/ /03/ /03/ /05/2018 Sponsor 1

2 of First 17/LO/ /LO/ /LO/ /LO/ fmri Neurofeedback as a novel neurotherapy for children with ADHD Monitoring quality of dementia care - preliminary evaluation of the MABLE interface for automated evaluation of caregiver interactions A phase II randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety,and tolerability of orally administered BI during a 52-week treatment period for the prevention of firstepisode of psychosis in subjects with attenuated psychosis syndrome. Use of blue blocking glasses in mania: a feasibility study 21/07/ /12/ /12/ /01/ /01/ /01/ /02/2018 Please Select... 15/09/ /10/ /02/ /03/ /03/ /03/ /06/2018 Neither 17/10/ /01/ /12/ /01/ /02/ /07/2018 Both 02/10/ /01/ /01/ /01/ /01/ /01/ /07/2018 Sponsor 17/LO/ Psychiatric Nursing Observation at night: a single case experimental design (SCED) 17/10/ /11/ /11/ /01/ /01/ /01/ /05/2018 Both 17/LO/ Testing The Feasibility And Acceptability Of A New Personalised Form Of Cognitive Remediation Therapy (pcrt) For People With Psychosis 25/10/ /01/ /01/ /02/ /02/ /02/ /09/2018 Sponsor 18/LO/ COMPASS Study: A study to examine the use of Virtual Reality (VR) to enhance self-compassion and motivation in a group of patients with Anorexia Nervosa. 20/12/ /02/ /02/ /05/ /05/ /05/ /05/2018 Sponsor 2

3 of First 18/LO/ Feasibility and acceptability of a randomised controlled trial of an integrated group intervention to reduce intimate partner violence perpetration among men receiving treatment for substance use 01/03/ /03/ /04/ /05/ /05/ /05/ /07/2018 Sponsor 18/SC/ EFFIP (E-support for Families and Friends of Individuals affected by Psychosis): A randomised controlled trial of a coproduced online intervention for carers 07/02/ /03/ /02/ /03/ /03/ /03/ /03/2018 Please Select... 18/LO/ /SC/ Evaluating the feasibility and acceptability of a novel mobile intervention targeting social cognition in individuals with psychosis. Interventional, randomised, double-blind, active-controlled study on the efficacy of Lu AF35700 in patients with early-indisease or late-in-disease treatment resistant schizophrenia 26/02/ /04/ /06/ /07/ /07/ /07/ /08/2018 Sponsor 19/01/ /03/ /01/ /04/ /04/ /04/ /06/2018 Neither 18/LO/ /LO/ A Multicentre, 8-week, Single-arm, Openlabel, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine with Healthcare Professionals and Adult Subjects with Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone) Can imagination change upsetting memories of trauma? 18/04/ /04/ /03/ /06/ /06/ /06/2018 Sponsor 22/03/ /05/ /05/ /07/ /07/ /07/ /08/2018 NHS Provider 3

4 of First 18/LO/ /LO/ /YH/ /WA/ /LO/ The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness & cost effectiveness of a team-based motivational engagement intervention to improve engagement Craving Induction and Imagery-based Coping for Cocaine Use Disorder: Clinical Study A randomized, double-blind, placebocontrolled, two-cohort parallel group study to evaluate the efficacy of CAD106 and CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer s disease A Phase 3, multicenter, randomized, double-blind, placebocontrolled, paralleldesign study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6- DM]/ quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer s type. A Validation Study of a computerized, Artificial Intelligence assisted cognitive assessment test compared to a widely used cognitive assessment test and specialist clinical diagnosis in patients with Alzheimer s Dementia and Mild Cognitive Impairment 14/05/ /05/ /05/ /10/ /10/ /10/2018 Sponsor 16/05/ /07/ /07/ /09/ /09/ /09/2018 Both 29/08/ /08/ /11/ /08/ /08/ /08/2018 Neither 25/04/ /07/ /07/ /07/ /08/ /08/2018 Neither 15/06/ /08/ /06/ /08/ /09/ /09/2018 Please Select... 4

5 of First 18/EE/ A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies (DELPHIA) 24/07/ /09/ /07/ /09/ /10/ /10/2018 Please Select... 18/LO/ The Safety and Efficacy of Psilocybin in s with Treatment-Resistant Depression (P-TRD) 24/07/ /07/ /07/ /08/ /08/ /08/2018 NHS Provider 18/LO/ A Global PRospective, Multi-cEnter, ObServational post-market Study to assess short, mid and long-term Effectiveness and efficiency of VNS Therapy as adjunctive therapy in realworld patients with difficult to treat depression. 14/05/ /09/ /06/ /09/ /09/ /09/2018 Please Select... 18/LO/ The Effects of Psilocybin on Cognitive Function in Healthy s 24/07/ /07/ /07/ /08/ /08/ /08/2018 Please Select... 5