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1. The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

Author

Irish, Madeleine, Dalton, Bethan, Potts, Laura, McCombie, Catherine, Shearer, James, Au, Katie, Kern, Nikola, Clark-Stone, Sam, Connan, Frances, Johnston, A. Louise, Lazarova, Stanimira, Macdonald, Shiona, Newell, Ciarán, Pathan, Tayeem, Wales, Jackie, Cashmore, Rebecca, Marshall, Sandra, Arcelus, Jon, Robinson, Paul, Himmerich, Hubertus, Lawrence, Vanessa C., Treasure, Janet, Byford, Sarah, Landau, Sabine, and Schmidt, Ulrike

Published
2022
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3. Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.

Author

İnce, Başak, Phillips, Matthew D., Zenasni, Zohra, Shearer, James, Dalton, Bethan, Irish, Madeleine, Mercado, Daniela, Webb, Hannah, McCombie, Catherine, Au, Katie, Kern, Nikola, Clark‐Stone, Sam, Connan, Frances, Johnston, A. Louise, Lazarova, Stanimira, Zadeh, Ewa, Newell, Ciarán, Pathan, Tayeem, Wales, Jackie, and Cashmore, Rebecca

Subjects
ANOREXIA nervosa treatment, PATIENT selection, PATIENT compliance, BODY mass index, QUALITATIVE research, RESEARCH funding, HUMAN research subjects, PATIENT care, DESCRIPTIVE statistics, RANDOMIZED controlled trials, THEMATIC analysis, TREATMENT failure, PATIENT aftercare, PATIENT participation, PATIENTS' attitudes
Abstract

Objective: The relative merits of inpatient or day‐treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non‐inferiority of a stepped‐care day patient treatment (DPT) approach versus inpatient treatment as usual (IP‐TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. Method: Fifteen patients with AN (of 53 approached) participated and were followed‐up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. Results: At baseline, participants in both trial arms rated stepped‐care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). Conclusions: No conclusions can be drawn concerning the effectiveness of IP‐TAU and stepped‐care DPT, but the latter was perceived more positively. Patient‐related, service‐related and systemic factors (COVID‐19) contributed to the trial's failure. Lessons learnt can inform future studies. Highlights: Patient‐related (e.g., treatment preferences) and service‐related (e.g., reduced service capacity) alongside wider systemic (e.g., increased emergency admissions due to COVID‐19) factors seem to have contributed to the failure of the DAISIES trial.Patients and carers identified valued aspects for both inpatient (e.g., weight gain) and day‐patient (e.g., greater link to home environment) treatment settings, but day‐patient treatment was perceived as a more holistic and collaborative approach, and thus as more positive.Although randomised controlled studies investigating intensive treatments for severe anorexia nervosa are important and necessary, alternative study designs should be explored to overcome implementation challenges. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study

Author

Dalton, Bethan, primary, Bartholdy, Savani, additional, McClelland, Jessica, additional, Kekic, Maria, additional, Rennalls, Samantha J, additional, Werthmann, Jessica, additional, Carter, Ben, additional, O’Daly, Owen G, additional, Campbell, Iain C, additional, David, Anthony S, additional, Glennon, Danielle, additional, Kern, Nikola, additional, and Schmidt, Ulrike, additional

Published
2018
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7. Additional file 2: of The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder

Author

Robinson, Paul, Hellier, Jennifer, Barrett, Barbara, Barzdaitiene, Daiva, Bateman, Anthony, Bogaardt, Alexandra, Clare, Ajay, Somers, Nadia, O’Callaghan, Aine, Goldsmith, Kimberley, Kern, Nikola, Schmidt, Ulrike, Morando, Sara, Ouellet-Courtois, Catherine, Roberts, Alice, Skårderud, Finn, and Fonagy, Peter

Abstract

CONSORT 2010 checklist. (DOCX 209 kb)

Published
2016
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8. Additional file 1: Figure S1. of The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder

Author

Robinson, Paul, Hellier, Jennifer, Barrett, Barbara, Barzdaitiene, Daiva, Bateman, Anthony, Bogaardt, Alexandra, Clare, Ajay, Somers, Nadia, O’Callaghan, Aine, Goldsmith, Kimberley, Kern, Nikola, Schmidt, Ulrike, Morando, Sara, Ouellet-Courtois, Catherine, Roberts, Alice, Skårderud, Finn, and Fonagy, Peter

Abstract

Unadjusted mean EDE and ZAN score by treatment group for all post randomisation time points and baseline (time 0). Lowest score if best. Error bars show 95Â % CI. EDE Eating Disorder Examination, ZAN Zanarini Rating Scale. (DOCX 74 kb)

Published
2016
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9. Additional file 1: of Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial

Author

Savani Bartholdy, McClelland, Jessica, Kekic, Maria, O’Daly, Owen, Campbell, Iain, Werthmann, Jessica, Rennalls, Samantha, Rubia, Katya, David, Anthony, Glennon, Danielle, Kern, Nikola, and Schmidt, Ulrike

Subjects
education
Abstract

TIARA study schedule of enrolment, interventions and assessments. This table presents the time schedule of enrolment, interventions and assessments, consistent with the figure provided in the SPIRIT Statement (2013) recommendations for reporting protocols. (DOCX 20 kb)

Published
2015
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10. The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder

Author

Robinson, Paul, primary, Hellier, Jennifer, additional, Barrett, Barbara, additional, Barzdaitiene, Daiva, additional, Bateman, Anthony, additional, Bogaardt, Alexandra, additional, Clare, Ajay, additional, Somers, Nadia, additional, O’Callaghan, Aine, additional, Goldsmith, Kimberley, additional, Kern, Nikola, additional, Schmidt, Ulrike, additional, Morando, Sara, additional, Ouellet-Courtois, Catherine, additional, Roberts, Alice, additional, Skårderud, Finn, additional, and Fonagy, Peter, additional

Published
2016
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11. Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial

Author

Bartholdy, Savani, primary, McClelland, Jessica, additional, Kekic, Maria, additional, O’Daly, Owen G., additional, Campbell, Iain C., additional, Werthmann, Jessica, additional, Rennalls, Samantha J., additional, Rubia, Katya, additional, David, Anthony S., additional, Glennon, Danielle, additional, Kern, Nikola, additional, and Schmidt, Ulrike, additional

Published
2015
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12. Paraoxon Sensitive Phenylvalerate Hydrolase in Assessing the Severity of Acute Paraoxon Poisoning

Author

Petroianu, Georg, Karcher, Bettina, Kern, Nikola, Bergler, Wolfgang, and Rufer, Roderich

Subjects
Organophosphorus compounds -- Health aspects, Poisoning, Accidental -- Care and treatment, Environmental issues, Health, Pharmaceuticals and cosmetics industries
Abstract

Introduction: Intoxications with organophosphorous compounds, especially paraoxon, are frequent. Organophosphorous compounds inhibit serine hydrolases such as acetylcholine, butyrylcholine, and carboxyl esterases although acetylcholine and butyrylcholine are too sensitive to paraoxon to be useful markers of severity. They cannot show a dose-dependent inhibition during an acute organophosphorous compounds exposure because maximal enzyme inhibition is reached at very low organophosphorous compounds concentrations. Purpose: To determine in vitro the dose-effect relationship between the activity of the paraoxon-sensitive phenylvalerate hydrolase, a member of the carboxyl esterases family, and the paraoxon dose, and to assess its utility as a putatively less sensitive enzyme marker to monitor the severity of an acute paraoxon intoxication. Materials and Methods: Phenylvalerate hydrolase and butyrylcholine activities were determined in serum of nine healthy human volunteers before and after addition of different concentrations of paraoxon. The determination of phenyl-valerate hydrolase activity was carried out using a modification of the method described by Johnson. A commercially available kit was used to measure butyrylcholine activity. Results: Paraoxon inhibits phenyl-valerate hydrolase activity at concentrations above [10.sup.-9] M. Maximal inhibition ([approximately equals] 50% of baseline) is achieved at concentrations above 2.5 x [10.sup.-7] M. The [IC.sub.50] value of paraoxon for phenyl-valerate hydrolase is 34 [+ or -] 2 nM. The uninhibited phenyl-valerate hydrolase activity is due to paraoxon-resistent isoforms. Paraoxon begins inhibiting butyrylcholine activity at concentrations above [10.sup.-9] m. At concentrations above 5 x [10.sup.-5] M, no butyrylcholine activity is measurable. The [IC.sub.50] value of paraoxon for butyrylcholine is 150 [+ or -] 23 nM. Conclusion: The paraoxon-sensitive subunit of phenyl-valerate hydrolase shows dose-dependent inhibition when exposed to paraoxon in vitro, but it is even more sensitive than butyrylcholine to paraoxon inhibition. Determinations of phenyl-valerate hydrolase activity to assess the severity of an acute organophosphorous compounds poisoning cannot be recommended, but phenyl-valerate hydrolase may have utility in worker surveillance., INTRODUCTION Orgaophosphorus compounds (OPCs) are widely used as pesticides in both agricultural and domestic settings, as softening agents and additives to lubricants in industry and technology, and as chemical weapons [...]

Published
2001

13. Correction: Harnessing Clinical Psychiatric Data with an Electronic Assessment Tool (OPCRIT+): The Utility of Symptom Dimensions

Author

Brittain, Philip James, primary, Lobo, Sarah Elizabeth Margaret, additional, Rucker, James, additional, Amarasinghe, Myanthi, additional, Anilkumar, Anantha Padmanabha Pillai, additional, Baggaley, Martin, additional, Banerjee, Pallavi, additional, Bearn, Jenny, additional, Broadbent, Matthew, additional, Butler, Matthew, additional, Campbell, Colin Donald, additional, Cleare, Anthony James, additional, Dratcu, Luiz, additional, Frangou, Sophia, additional, Gaughran, Fiona, additional, Goldin, Matthew, additional, Henke, Annika, additional, Kern, Nikola, additional, Krayem, Abdallah, additional, Mufti, Faiza, additional, McIvor, Ronan, additional, Needham-Bennett, Humphrey, additional, Newman, Stuart, additional, Olajide, Dele, additional, O’Flynn, David, additional, Rao, Ranga, additional, Rehman, Ijaz Ur, additional, Seneviratne, Gertrude, additional, Stahl, Daniel, additional, Suleman, Sajid, additional, Treasure, Janet, additional, Tully, John, additional, Veale, David, additional, Stewart, Robert, additional, McGuffin, Peter, additional, Lovestone, Simon, additional, Hotopf, Matthew, additional, and Schumann, Gunter, additional

Published
2013
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14. Harnessing Clinical Psychiatric Data with an Electronic Assessment Tool (OPCRIT+): The Utility of Symptom Dimensions

Author

Brittain, Philip James, primary, Lobo, Sarah Elizabeth Margaret, additional, Rucker, James, additional, Amarasinghe, Myanthi, additional, Anilkumar, Anantha Padmanabha Pillai, additional, Baggaley, Martin, additional, Banerjee, Pallavi, additional, Bearn, Jenny, additional, Broadbent, Matthew, additional, Butler, Matthew, additional, Campbell, Colin Donald, additional, Cleare, Anthony James, additional, Dratcu, Luiz, additional, Frangou, Sophia, additional, Gaughran, Fiona, additional, Goldin, Matthew, additional, Henke, Annika, additional, Kern, Nikola, additional, Krayem, Abdallah, additional, Mufti, Faiza, additional, McIvor, Ronan, additional, Needham-Bennett, Humphrey, additional, Newman, Stuart, additional, Olajide, Dele, additional, O’Flynn, David, additional, Rao, Ranga, additional, Rehman, Ijaz Ur, additional, Seneviratne, Gertrude, additional, Stahl, Daniel, additional, Suleman, Sajid, additional, Treasure, Janet, additional, Tully, John, additional, Veale, David, additional, Stewart, Robert, additional, McGuffin, Peter, additional, Lovestone, Simon, additional, Hotopf, Matthew, additional, and Schumann, Gunter, additional

Published
2013
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17. Combined effects of exonic polymorphisms in CRHR1 and AVPR1B genes in a case/control study for panic disorder

Author

Keck, Martin E., primary, Kern, Nikola, additional, Erhardt, Angelika, additional, Unschuld, Paul G., additional, Ising, Marcus, additional, Salyakina, Daria, additional, Müller, Marianne B., additional, Knorr, Carolin C., additional, Lieb, Roselind, additional, Hohoff, Christa, additional, Krakowitzky, Petra, additional, Maier, Wolfgang, additional, Bandelow, Borwin, additional, Fritze, Jürgen, additional, Deckert, Jürgen, additional, Holsboer, Florian, additional, Müller‐Myhsok, Bertram, additional, and Binder, Elisabeth B., additional

Published
2008
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18. Association of polymorphisms in P2RX7 and CaMKKb with anxiety disorders

Author

Erhardt, Angelika, primary, Lucae, Susanne, additional, Unschuld, Paul G., additional, Ising, Marcus, additional, Kern, Nikola, additional, Salyakina, Daria, additional, Lieb, Roselind, additional, Uhr, Manfred, additional, Binder, Elisabeth B., additional, Keck, Martin E., additional, Müller-Myhsok, Bertram, additional, and Holsboer, Florian, additional

Published
2007
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21. Polymorphisms in FKBP5 are associated with increased recurrence of depressive episodes and rapid response to antidepressant treatment

Author

Binder, Elisabeth B, primary, Salyakina, Daria, additional, Lichtner, Peter, additional, Wochnik, Gabriele M, additional, Ising, Marcus, additional, Pütz, Benno, additional, Papiol, Sergi, additional, Seaman, Shaun, additional, Lucae, Susanne, additional, Kohli, Martin A, additional, Nickel, Thomas, additional, Künzel, Heike E, additional, Fuchs, Brigitte, additional, Majer, Matthias, additional, Pfennig, Andrea, additional, Kern, Nikola, additional, Brunner, Jürgen, additional, Modell, Sieglinde, additional, Baghai, Thomas, additional, Deiml, Tobias, additional, Zill, Peter, additional, Bondy, Brigitta, additional, Rupprecht, Rainer, additional, Messer, Thomas, additional, Köhnlein, Oliver, additional, Dabitz, Heike, additional, Brückl, Tanja, additional, Müller, Nina, additional, Pfister, Hildegard, additional, Lieb, Roselind, additional, Mueller, Jakob C, additional, Lõhmussaar, Elin, additional, Strom, Tim M, additional, Bettecken, Thomas, additional, Meitinger, Thomas, additional, Uhr, Manfred, additional, Rein, Theo, additional, Holsboer, Florian, additional, and Muller-Myhsok, Bertram, additional

Published
2004
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23. Polymorphisms in the serotonin receptor gene HTR2A are associated with quantitative traits in panic disorder

Author

Unschuld, Paul G., Ising, Marcus, Erhardt, Angelika, Lucae, Susanne, Kloiber, Stefan, Kohli, Martin, Salyakina, Daria, Welt, Tobias, Kern, Nikola, Lieb, Roselind, Uhr, Manfred, Binder, Elisabeth B., Müller‐Myhsok, Bertram, Holsboer, Florian, and Keck, Martin E.

Abstract

Anxiety disorders and specifically panic disorder (PD) are caused by complex interactions of environmental and genetic factors. The latter comprise many different genes, from which those involved in serotonergic neurotransmission have received particular attention. Here we report the results from an association candidate‐gene approach, where we analyzed 15 single nucleotide polymorphisms (SNPs) within the gene coding for the serotonin‐receptor 2A (HTR2A) in patients suffering from PD and a control sample. We found that the SNP rs2296972 shows an association between the number of T‐alleles and severity of symptoms in PD. By performing tests according to the Fisher product method (FPM), an association between HTR2A and the personality trait reward dependence could be shown. Most pronounced effects were observable for the SNPs rs2770304, rs6313, and rs6311. Furthermore, the polymorphisms rs3742278, rs2296972, and rs2770292 form a haplotype, which may be associated with higher susceptibility for PD. These results further underline a possible important role of genetic variations within the system controlling serotonergic neurotransmission for the development and course of disease in PD. © 2007 Wiley‐Liss, Inc.

Published
2007
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24. Polymorphisms in the galanin gene are associated with symptom–severity in female patients suffering from panic disorder

Author

Unschuld, Paul G., Ising, Marcus, Erhardt, Angelika, Lucae, Susanne, Kohli, Martin, Kloiber, Stefan, Salyakina, Daria, Thoeringer, Christoph K., Kern, Nikola, Lieb, Roselind, Uhr, Manfred, Binder, Elisabeth B., Müller-Myhsok, Bertram, Holsboer, Florian, and Keck, Martin E.

Subjects
*GENETIC polymorphisms, *PATHOLOGICAL psychology, *PANIC disorders, *ANXIETY
Abstract

Abstract: Background: Galanin (GAL) is a neuropeptide, which is expressed primarily in limbic nuclei in the brain and mediates miscellaneous physiological processes and behaviors. In animal studies, both the application of GAL and antagonism of its receptors have been shown to affect anxiety-like and depression-related behavior. In humans, intravenous administration of the neuropeptide galanin has been reported to have fast antidepressant efficacy. Furthermore, GAL is involved in hypothalamic–hypophysiotropic signalling and cosecreted with luteinizing hormone-releasing hormone (LHRH), possibly acting as a mediator of estrogen action. Methods: In this study six single nucleotide polymorphisms (SNPs) within the gene coding for GAL were analyzed for possible associations with diagnosis and severity of symptoms in 121 male and female patients suffering from panic disorder (PD). Results: Our results suggest an association between genetic variations in the GAL-gene and severity of PD-symptoms in female patients. The most pronounced effects could be observed for two haplotypes containing the closely linked, non-protein-coding SNPs rs948854 and rs4432027. Both polymorphisms are located within CpG-dinucleotides in the promoter region of GAL and thus might be involved in epigenetic regulation of the GAL-gene. Limitations: A relatively small patient sample was analyzed in this study, the herein presented results need to be validated in independent studies. Conclusions: The results of this study underline the potential of further genetic research concerning GAL and a possible role of this neuropeptide in the pathogenesis of female PD. In this regard, GAL and its receptors appear to be a promising target for pharmacological therapy of anxiety and affective disorders. [Copyright &y& Elsevier]

Published
2008
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