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Clinical Trials/ISRCTN10963342
ISRCTN10963342
Completed
未知

Randomised controlled trial of the clinical and cost effectiveness of a specialist mood disorders team for refractory unipolar depressive disorder

niversity of Nottingham0 sites222 target enrollmentNovember 25, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Mental Health
Sponsor
niversity of Nottingham
Enrollment
222
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2010 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21114826 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27498098 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29902995 qualitative study results 2023 Results article in https://doi.org/10.1016/j.jad.2023.10.105 Follow up results (added 23/10/2023)

Registry
who.int
Start Date
November 25, 2015
End Date
July 11, 2013
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Nottingham

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged over 18 years
  • 2\. Able and willing to give oral and written informed consent to participate in the study
  • 3\. Suffering from primary unipolar depression which is not a consequence of having another axis 1 or 2 psychiatric disorder
  • 4\. From the date of first assessment by a health professional working within the index mental health trust, primary care trust or third sector, they must have been offered or received direct and continuous care from one or more health professionals in the preceding 6 months. They must currently be under the care of a secondary care mental health team.
  • 5\. Meets NICE criteria for moderate depression (five out of nine symptoms of depression (NICE, 2004\)); has a Hamilton Depression Rating Scale of at least 16; and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994\).

Exclusion Criteria

  • 1\. Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk. However, patients will not be excluded because of such risk provided the risk is adequately contained within their current care setting and the primary medical responsibility for care remains with the referring team.
  • 2\. Does not speak fluent English
  • 3\. Pregnancy (female participants)

Outcomes

Primary Outcomes

Not specified

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