Chronic Unipolar Depressive Disorder Clinical Trial
Official title:
Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.
| Status | Recruiting |
| Enrollment | 219 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder. - Age over 18 years. - Able and willing to give oral and written informed consent to participation in the study. - From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months. - Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994). Exclusion Criteria: - Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team. - Does not speak fluent English. - Is pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Derbyshire Mental Health NHS Trust | Derby | Derbyshire |
| United Kingdom | Lincolnshire Partnership Trust | Lincoln | Lincolnshire |
| United Kingdom | Nottinghamshire Healthcare NHS Trust | Nottingham | Nottinghamshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham | National Institute for Health Research, United Kingdom |
United Kingdom,
Anderson IM, Ferrier IN, Baldwin RC, Cowen PJ, Howard L, Lewis G, Matthews K, McAllister-Williams RH, Peveler RC, Scott J, Tylee A. Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol. 2008 Jun;22(4):343-96. doi: 10.1177/0269881107088441. Epub 2008 Apr 15. — View Citation
Baker R, Reddish S, Robertson N, Hearnshaw H, Jones B. Randomised controlled trial of tailored strategies to implement guidelines for the management of patients with depression in general practice. Br J Gen Pract. 2001 Sep;51(470):737-41. — View Citation
Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. Review. — View Citation
Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31. Review. — View Citation
Parker GB, Malhi GS, Crawford JG, Thase ME. Identifying "paradigm failures" contributing to treatment-resistant depression. J Affect Disord. 2005 Aug;87(2-3):185-91. — View Citation
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. — View Citation
Sartorius N. The economic and social burden of depression. J Clin Psychiatry. 2001;62 Suppl 15:8-11. Review. — View Citation
Schramm E, Schneider D, Zobel I, van Calker D, Dykierek P, Kech S, Härter M, Berger M. Efficacy of Interpersonal Psychotherapy plus pharmacotherapy in chronically depressed inpatients. J Affect Disord. 2008 Jul;109(1-2):65-73. Epub 2007 Dec 11. — View Citation
Sheldon TA, Cullum N, Dawson D, Lankshear A, Lowson K, Watt I, West P, Wright D, Wright J. What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews. BMJ. 2004 Oct 30;329(7473):999. — View Citation
Warden D, Rush AJ, Trivedi MH, Fava M, Wisniewski SR. The STAR*D Project results: a comprehensive review of findings. Curr Psychiatry Rep. 2007 Dec;9(6):449-59. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale - Grid version | 6 months | No | |
| Secondary | Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology | 3 months | No | |
| Secondary | Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives. | 6 months | No | |
| Secondary | Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning. | 6 months | No | |
| Secondary | Patient satisfaction and patient/doctor relationship | 6 months | No |