Plain English Summary
Background and study aims
Depression in older people is common and leads to other problems. Two thirds of these patients will not have an improvement from routine treatment. About half have a form of depression known as vascular depression. Augmentation - in this case the addition to antidepressant treatment of a vascular type of treatment (such as a group of a medications called Calcium Channel Blockers including the medication called amlodipine) - may work but previously published studies have been from highly selected patient groups. We would like to find out if giving amlodipine medication to people with a late-life non-responding vascular type of depression would be acceptable to this patient group. We would also like to know how they feel while having the treatment , 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.
Who can participate?
Participants who 50 years old or over and have been diagnosed with depression which has not improved with other drugs. We call this type of depression vascular depression.
What does the study involve?
If a participant would like to be involved in this study, they would be required to attend the Clinical Ageing Research Unit (CARU) at the former Newcastle General Hospital site in Newcastle upon Tyne (UK) for up to seven visits. They would be required to take the study medication prescribed to them. The study medication may be either amlodipine or placebo. Neither the participant nor the doctor or nurses involved in the study will be aware of which medication has been given (this is called a double blind study, and is done to ensure that there is no other influence on the results apart from the effects of the drug itself). Each participant will be randomly allocated to receiving either amlodipine or placebo (process called randomisation).
At the first visit, participants will discuss the study in further detail and will have the opportunity to ask any questions. If they would like to be involved, they will be invited to return for a second visit at which time they will be asked to give their consent to be involved in the study. They will then need to have their blood pressure taken, have an ECG (electrocardiograph) to establish how well their heart is working, have a small blood sample taken and complete four short questionnaires.
Following on from this, the participant will be invited back for a second visit, which will also be used to confirm the participants eligibility. The participant will be required to have a physical examination, have their blood pressure checked and complete nine short questionnaires.
Once a participant has been confirmed as eligible for the study, they will be entered into the study and randomly allocated to either amlodipine or placebo. The participant will then receive four weeks supply of the study medication.
Two weeks after the second visit, and again at 6 and 12 weeks into the study, each participant will be contacted by the study research nurses in order to review how the participant has been since their last visit.
At weeks 4 and 8 of the study, participants will be required to attend the research centre for another visit, at which point they will be asked to complete two short questionnaires, have their blood pressure taken and current medication reviewed and they will receive their next supply of study medication.
At 16 weeks after starting the study, the study medication will be stopped and participants will be asked to attend another visit at which time current medication will be reviewed, blood pressure will be taken, as well as a blood sample, and participants will also be asked to complete eight short questionnaires. Depending on the results of these questionnaires, participants may be asked to attend for another visit a week later at which point their blood pressure will be taken and they will be asked to complete six short questionnaires.
At 20 weeks after the start of the study, patients will be asked to return for a final visit at which point they will be asked to complete two short questionnaires and have their blood pressure taken once more.
Following on from this study, participants will be returned to the care of their GP.
As part of this study, participants will also be invited to take part in an interview, which will involve the discussion of the various questionnaires undertaken in the study and any other concerns the participant may have had during the course of the study. These interviews will be optional and not be a required part of the study, should the participant decline to take part in the interviews they will still be able to remain on the main part of the study.
What are the possible benefits and risks of participating?
There is no guarantee that taking part in this study may benefit the participant, however it is anticipated that the active medication could reduce the symptoms of their depression. The risk involved in participating in this study is very small, and may include bruising or infection at the site of where the blood samples were taken. Other risks include the possible side effects of the study drug (amlodipine) which may include swelling of the ankles, dizziness, fatigue, nausea, indigestion, palipitations or headaches. These, and other side effects, are listed in the Patient Information Sheet which will be given to each potential participant for further information.
Where is the study run from?
Clinical Ageing Research Unit (CARU) at the former Newcastle General Hospital (UK).
When is the study starting and how long is it expected to run for?
The study will start around March 2013, and will run for approximately 24 months.
Who is funding the study?
The study is sponsored by Gateshead Health NHS Foundation Trust and is funded by National Institute for Health Reseach Research for Patient Benefit (UK).
Who is the main contact?
Julie Henry (Research Nurse) based at the Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL, UK, Telephone: +44 191 248 1280 (reception)
Trial website
Contact information
Type
Scientific
Primary contact
Miss Melinda Jeffels
ORCID ID
Contact details
4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
+44 191 222 7249
melinda.jeffels@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10869
Study information
Scientific title
Vascular Augmentation of Late-life Unremitted Depression: a randomised study
Acronym
VALUeD
Study hypothesis
Study aims:
1. 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
2. To assess how these patients feel while having the treatment and whether this provides a measureable benefit for those patients and whether those benefits are relevant to the patients
3. To find out the information we need to plan and prepare for a larger version of this study
Ethics approval
North West- Haydock Research Ethics Committee, 28/10/2011, ref: 11/NW/0551
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases
Intervention
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
Intervention type
Drug
Phase
Phase III
Drug names
Amlodipine
Primary outcome measure
Reponse rates to study invitation to GP practices and patients; Timepoint(s): For the entire study duration
Secondary outcome measures
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
Overall trial start date
01/03/2012
Overall trial end date
02/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 80; UK Sample Size: 80
Participant exclusion criteria
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)
Recruitment start date
01/03/2012
Recruitment end date
02/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list