Chronic Unipolar Depressive DisorderNCT01047124
Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
A study testing Specialist Mood Disorders Team in people with Chronic Unipolar Depressive Disorder, run by University of Nottingham at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Unipolar Depressive Disorder
- What is being tested?
- Specialist Mood Disorders Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2009to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Derbyshire Mental Health NHS Trust
Derby, Derbyshire
Marttunen, +44(0)1158232478
Paul Gilbert, MSc, PhD, Dip Clin Psyc, FBPsS
- Not yet recruiting
Lincolnshire Partnership Trust
Lincoln, Lincolnshire
Marttunen, +44(0)1158232478
Simon Loosmore, MB ChB, MRCpsych
- Recruiting
Nottinghamshire Healthcare NHS Trust
Nottingham, Nottinghamshire
Marttunen, +44(0)1158232478
Richard Morriss, MBChB, MRCpsych, MMedSci, MD
About this study
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.
Read the detailed description
A pragmatic randomised controlled trial of a specialist mood disorder intervention versus treatment as usual will be conducted. Patients will be individually randomised with stratification by mental health trust to either treatment by a specialist team offering tailored psychological and pharmacological treatment or treatment as usual.
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs. The participants in the treatment as usual team will have their usual access to the same treatments. The outcome in terms of improvement in depressive symptoms, function and costs will be examined after one year in service users with chronic depression.
Eligible patients will be followed for 12 months and the primary outcomes will be observer rated depressive symptoms and cost effectiveness from a health and social care perspective. Along side the RCT, implementation analysis and audit of the standard care and specialised care for depression will be carried out.
- Conditions
- Chronic Unipolar Depressive Disorder
- Being tested
- Specialist Mood Disorders Team
- Keywords
- Depression, Collaborative Care, Cognitive Behaviour Therapy, Mental Health Services, Antidepressants
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialist Mood Disorders TeamOther
Also called Collaborative care for depression
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Specialist mood disorders team: treatment plan according to need Receives: Other: Specialist Mood Disorders Team |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale - Grid version
Measured: 6 months
Secondary outcomes (4)
Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology
Measured: 3 months
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.
Measured: 6 months
Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.
Measured: 6 months
Patient satisfaction and patient/doctor relationship
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Unipolar Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Richard Morriss, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047124
- Sponsor's protocol ID
- 09044
- Status last verified
- Dec 2015
- First submitted
- 11 Jan 2010
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18413657Baker 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.
PubMed 11593835Gilbody 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. doi: 10.1001/archinte.166.21.2314.
PubMed 17130383Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.
PubMed 11480881Parker 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. doi: 10.1016/j.jad.2005.02.015.
PubMed 15979725Rush 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. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942Warden 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. doi: 10.1007/s11920-007-0061-3.
PubMed 18221624Sartorius N. The economic and social burden of depression. J Clin Psychiatry. 2001;62 Suppl 15:8-11.
PubMed 11444765Schramm E, Schneider D, Zobel I, van Calker D, Dykierek P, Kech S, Harter M, Berger M. Efficacy of Interpersonal Psychotherapy plus pharmacotherapy in chronically depressed inpatients. J Affect Disord. 2008 Jul;109(1-2):65-73. doi: 10.1016/j.jad.2007.10.013. Epub 2007 Dec 11.
PubMed 18067973Sheldon 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. doi: 10.1136/bmj.329.7473.999.
PubMed 15514342Sweeney T, Nixon E, Morriss R, Callaghan P. A qualitative exploration into the experience of mindfulness in moderate-severe persistent depression. PLoS One. 2025 Jun 9;20(6):e0323294. doi: 10.1371/journal.pone.0323294. eCollection 2025.
PubMed 40489493Nixon N, Guo B, Kaylor-Hughes C, Simpson S, Garland A, Dalgleish T, Morriss R. Specialist treatment for persistent depression in secondary care: Sustained effects from a multicentre UK study at 24 and 36 months. J Affect Disord. 2024 Jan 15;345:70-77. doi: 10.1016/j.jad.2023.10.105. Epub 2023 Oct 19.
PubMed 37863366Thomson L, Barker M, Kaylor-Hughes C, Garland A, Ramana R, Morriss R, Hammond E, Hopkins G, Simpson S. How is a specialist depression service effective for persistent moderate to severe depressive disorder?: a qualitative study of service user experience. BMC Psychiatry. 2018 Jun 15;18(1):194. doi: 10.1186/s12888-018-1708-9.
PubMed 29902995Morriss R, Garland A, Nixon N, Guo B, James M, Kaylor-Hughes C, Moore R, Ramana R, Sampson C, Sweeney T, Dalgleish T; NIHR CLAHRC Specialist Mood Disorder Study Group. Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial. Lancet Psychiatry. 2016 Sep;3(9):821-31. doi: 10.1016/S2215-0366(16)30143-2. Epub 2016 Aug 3.
PubMed 27498098Morriss R, Marttunnen S, Garland A, Nixon N, McDonald R, Sweeney T, Flambert H, Fox R, Kaylor-Hughes C, James M, Yang M. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder. BMC Psychiatry. 2010 Nov 29;10:100. doi: 10.1186/1471-244X-10-100.
PubMed 21114826
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
- ClinicalTrials.gov ID
- NCT01047124
- Acronym / sponsor ID
- 09044
- Conditions
- Chronic Unipolar Depressive Disorder
- Keywords
- Depression, Collaborative Care, Cognitive Behaviour Therapy, Mental Health Services, Antidepressants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2009
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A pragmatic randomised controlled trial of a specialist mood disorder intervention versus treatment as usual will be conducted. Patients will be individually randomised with stratification by mental health trust to either treatment by a specialist team offering tailored psychological and pharmacological treatment or treatment as usual.
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs. The participants in the treatment as usual team will have their usual access to the same treatments. The outcome in terms of improvement in depressive symptoms, function and costs will be examined after one year in service users with chronic depression.
Eligible patients will be followed for 12 months and the primary outcomes will be observer rated depressive symptoms and cost effectiveness from a health and social care perspective. Along side the RCT, implementation analysis and audit of the standard care and specialised care for depression will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Specialist Mood Disorders TeamSpecialist mood disorders team: treatment plan according to need |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialist Mood Disorders TeamAlso: Collaborative care for depressionThe specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs. | Other | Intervention |
Primary outcome
Hamilton Depression Rating Scale - Grid version
Time frame: 6 months
4 secondary outcomes
Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology
Time frame: 3 months
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.
Time frame: 6 months
Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.
Time frame: 6 months
Patient satisfaction and patient/doctor relationship
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 18413657Anderson 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.
- Background: PubMed 11593835Baker 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.
- Background: PubMed 17130383Gilbody 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. doi: 10.1001/archinte.166.21.2314.
- Background: PubMed 11480881Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.
- Background: PubMed 15979725Parker 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. doi: 10.1016/j.jad.2005.02.015.
- Background: PubMed 17074942Rush 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. doi: 10.1176/ajp.2006.163.11.1905.
- Background: PubMed 18221624Warden 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. doi: 10.1007/s11920-007-0061-3.
- Background: PubMed 11444765Sartorius N. The economic and social burden of depression. J Clin Psychiatry. 2001;62 Suppl 15:8-11.
- Background: PubMed 18067973Schramm E, Schneider D, Zobel I, van Calker D, Dykierek P, Kech S, Harter M, Berger M. Efficacy of Interpersonal Psychotherapy plus pharmacotherapy in chronically depressed inpatients. J Affect Disord. 2008 Jul;109(1-2):65-73. doi: 10.1016/j.jad.2007.10.013. Epub 2007 Dec 11.
- Background: PubMed 15514342Sheldon 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. doi: 10.1136/bmj.329.7473.999.
- Derived from this study: PubMed 40489493Sweeney T, Nixon E, Morriss R, Callaghan P. A qualitative exploration into the experience of mindfulness in moderate-severe persistent depression. PLoS One. 2025 Jun 9;20(6):e0323294. doi: 10.1371/journal.pone.0323294. eCollection 2025.
- Derived from this study: PubMed 37863366Nixon N, Guo B, Kaylor-Hughes C, Simpson S, Garland A, Dalgleish T, Morriss R. Specialist treatment for persistent depression in secondary care: Sustained effects from a multicentre UK study at 24 and 36 months. J Affect Disord. 2024 Jan 15;345:70-77. doi: 10.1016/j.jad.2023.10.105. Epub 2023 Oct 19.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Morriss principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialist Mood Disorders Team in people with Chronic Unipolar Depressive Disorder, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah E Marttunen, MSc (+44(0)1158232478, sarah.marttunen@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale - Grid version (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047124, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.