1. Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Petter Viksveen Post-graduate Research Student University of Sheffield Supervisors: Prof. Paul Bissell, Dr. Clare Relton

2. Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Aim: acceptability & clinical & cost effectiveness homeopathic treatment in addition to usual care

3. Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Aim: acceptability & clinical & cost effectiveness homeopathic treatment in addition to usual care self-reported depression

4. We hope the cmRCT model will help with Improved recruitment rates Representative population Reduced attrition rates

5. We hope the cmRCT model will help with Improved recruitment rates Representative population Reduced attrition rates Save time

6. South Yorkshire Cohort (n=20,000) Self-reported long-standing depression (n=1,800) Mail out Mood & Health Questionnaire Completed Mood & Health Questionnaire (est. n=700)

7. References Adler U.C., Kruger S., Teut M., Ludtke R., Bartsch I., Schutzler L., Melcher F., Willich S.N., Linde K., & Witt C.M. (2011). Homeopathy for depression – DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials, 12:43. Doi:10.1186/1745-6215-12-43. Adler U.C., Paiva N.M.P., Cesar A.T., Adler M.S., Molina A., Padula A.E., & Calil H.M. (2009). Homeopathic individualized q-potencies versus Fluoxetine for moderate to severe depression: Double- blind, randomized non-inferiority trial. eCAM. Doi:10.1093/ecam/nep114 Bell I.R., Lewis D.A., Brooks A.J., Schwartz G.E., Lewis S.E., Walsh B.T., & Baldwin C.M. (2004). Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology. Doi:10.1093/rheumatology/keh111 Clover A. (2000). Patient benefit survey: Tunbridge Wells Homoeopathic Hospital. Br Homeopath J, 89:68.72. Davidson J.R.T., Morrison RM., Shore J., Davison R.T., & Bedayn G. (1997). Homeopathic treatment of depression and anxiety. Altern Ther Health Med, 3(1):46–49. EU Clinical Trials Register. (2011). EudraCT Number: 2009-017458-11. Heulluy B. (1982). Essai randomize ouvert de L 72 (spécialité homéopathique) contre diazepam 2 dans les états anxiodépressifs. [Open randomized trial comparing L.72 with Diazepam 2 in states of nervous depression.] [French] Metz: Laboratoires Lehning. Unpublished study. Katz T., Fisher P., Katz A., Davidson J., & Feder G. (2005). The feasibility of a randomised, placebo- controlled clinical trial of homeopathic treatment of depression in general practice. Homeopathy, 94:145- 152. Mathie R.T., & Robinson T.W. (2006). Outcomes from homeopathic prescribing in medical practice: A prospective, research-targeted, pilot study. Homeopathy, 95:199-205.

8. McDade D. (2008). Evaluation – Complementary and alternative medicines pilot project in Northern Ireland. Department of Health, Social Services and Public Safety. May. Pilkington K., Kirkwood G., Rampes H., Fisher P., & Richardson J. (2005). Homeopathy for depression: a systematic review of the research evidence. Homeopathy, 94:153-163. Relton C., Torgerson D., O’Cathain A., & Nicholl J. (2010). Rethinking pragmatic RCTs: introducing the ‘cohort multiple RCT’ design. BMJ, 340:c1066. Richardson W.R. (2001). Patient benefit survey: Liverpool Regional Department of Homoeopathic Medicine. Br Homeopath J, 90(3):158-62. Sevar R. (2000). Audit of outcome in 829 consecutive patients treated with homeopathic medicines. Br Homoeopat J, 89(4):178-87. Sevar R. (2005). Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy, 94(4):215-21. Slade K., Chohan B.P.S., & Barker P.J. (2004). Evaluation of a GP practice based homeopathy service. Homeopathy, 93(2):67-70. Spence D.S., Thompson E.A., & Barron S.J. (2005). Homeopathic treatment for chronic disease: a 6- year, university-hospital outpatient observational study. J Altern Complement Med, 11(5):793-8. Thompson E.A., Reilly D. (2002). The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliat Med, 16 (3):227-33. Thompson E.A., Reilly D. (2003). The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy, 92(3):131-4. Tölg M. (2006). Amanita muscaria: The efficacy and safety of a homeopathic drug in patients with nervous states of disquiet and excitation - Results of an observational study. Ärztezeit Naturheilverf Regul, 47(6):415-419.