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ISRCTN
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ISRCTN46911260
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ClinicalTrials.gov identifier
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Public title
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Vascular Augmentation of Late-life Unremitted Depression
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Scientific title
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Vascular Augmentation of Late-life Unremitted Depression: a randomised study
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Acronym
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VALUeD
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Serial number at source
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10869
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Study hypothesis
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Depression has a high occurrence and causes other problems in older people, two thirds of these patients will not have a lessening in their condition from routine treatment medication. About half have a form of depression known as vascular depression. Augmentation, the addition to, antidepressant treatment with a vascular type of treatment (such as a group of a medications called Calcium Channel Blocker including the medication called amlodipine) may be effective in this group of patients but previously published studies have been from highly selected specific patient groups. We would like to find out if giving amlodipine medication to people with a late life non-responding vascular type depression would be acceptable to this patient group. We would also like to know how they feel while having the treatment and whether this provides a measureable benefit for those patients and whether those benefits are relevant to the patients. We would also like to find out the information we need to plan and prepare for a larger version of this study.
The main outcome measure is the Hamilton Rating Scale for Depression (HAMD), which is the standard rating scale for interventional studies in depression. We will also use the Clinical Global Impression (CGI) Severity and Improvement instruments, which are standard global ratings of outcome used in such depression intervention studies. We will therefore use the 15item Geriatric Depression Scale (GDS), a functional rating scale (IADL 32) which has been used in a several observational studies in older people and the Euroquol 5D to assess quality of life. Although the primary outcome is remission on the HAMD, an important question is whether this best captures improvements in depression which matter to patients. We are therefore including a qualitative analysis of a subset of the subjects to investigate the appropriateness and acceptability of these outcomes from the patients’ perspective, using focus group and 1 to 1 interviews.
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10869
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Lay summary
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Lay summary under review
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Ethics approval
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North West- Haydock Research Ethics Committee First MREC approval date 28/10/2011, ref: 11/NW/0551
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Study design
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Randomised; Interventional; Design type: Treatment
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases
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Participants - inclusion criteria
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1. Age 50 years and over
2. Clinically significant (unremitted) vascular depression, as defined above
3. Mini mental state examination (MMSE) >23
4. Medically stable
5. BP < 150/90 (QoF Audit standard)
6. Patient has provided written informed consent for participation in the study prior to any study specific procedures. ; Lower Age Limit 50 years
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Participants - exclusion criteria
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1. Taking a calcium channel blocker
2. Clinical evidence of dementia
3. History or clinical evidence of stroke
4. History of bipolar or psychotic disorder
5. Significant suicide risk
6. Known hypersensitivity to amlodipine or any other calcium channel blocker
7. Severe renal or hepatic impairment
8. Pregnancy, or women planning to become pregnant within next 12 months, or women who are breast feeding
9. Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)
10. Previous participation in this study
11. Presence of cardiac pace-maker or other contraindications to (only applies to those consenting to MRI sub-study)
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Anticipated start date
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01/03/2012
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Anticipated end date
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02/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 80; UK Sample Size: 80
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Interventions
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Study medication, Patients will be randomised to receive either amlodipine or placebo, and will be advised to take 5mg/day for the first four weeks, then up to a maximum dose of 10mg/day for the next 12 weeks. The dose of either can be titrated down to 5mg again if required.; Study Entry : Single Randomisation only
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Primary outcome measure(s)
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To determine reponse rates to study invitation to GP practices and patients; Timepoint(s): For the entire study duration
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Secondary outcome measure(s)
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1. Blood pressure changes reported; Timepoint(s): at 16 weeks
2. Evaluation of effect on perfusion as determined by second MRI; Timepoint(s): at 16 weeks
3. Measure remission by 16 weeks of augmentation; Timepoint(s): 16 weeks, at end of study
4. Quality of Life questionnaire reporting differences; Timepoint(s): 16 weeks
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Sources of funding
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National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB) Grant Codes: PB-PG-0609-19028
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Trial website
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Publications
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Contact name
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Miss
Melinda
Jeffels
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Address
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4th Floor William Leech Building
Framlington Place
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City/town
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Newcastle Upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Email
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melinda.jeffels@newcastle.ac.uk
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Sponsor
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Gateshead Health NHS Foundation Trust (UK)
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Address
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Queen Elizabeth Hospital, Sheriff Hill
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City/town
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Gateshead
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Zip/Postcode
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NE9 6SX
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Country
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United Kingdom
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Date applied
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31/01/2012
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Last edited
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13/02/2012
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Date ISRCTN assigned
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31/01/2012
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