Condition category
Mental and Behavioural Disorders
Date applied
31/01/2012
Date assigned
31/01/2012
Last edited
24/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Gateshead Health NHS Foundation Trust (UK)

Sponsor details

Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/06/2016: No publications found, verifying study status with principal investigator.