DepressionPhase 3VALUeDNCT01557153
Vascular Augmentation of Late-life Unremitted Depression (VALUeD)
A Phase 3 study testing Amlodipine in people with Depression, run by Gateshead Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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'. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Apr 2014
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years or more
- Clinically significant (unremitted) vascular depression, as defined above.
- MMSE > 23
- BP < 150/90 (QoF Audit standard)
- Patient has provided written informed consent for participation in the study prior to any study specific procedures
Who cannot join
- Taking a calcium channel blocker
- Clinical evidence of dementia
- History or clinical evidence of stroke
- History of bipolar or psychotic disorder
- Significant suicide risk
- Known hypersensitivity to amlodipine or any other calcium channel blocker
Show all 10Show fewer
- Severe renal or hepatic impairment
- Pregnancy, or women planning to become pregnant within next 12 months, or women who are breast feeding
- Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)
- Presence of cardiac pace-maker or other contraindications to (only applied to those consenting MRI sub-study)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Ageing Research Unit
Newcastle upon Tyne, NE4 5PL
Susan Atkinson, +44(0)1912481267, susan.atkinson@ncl.ac.uk
Alan Thomas, Dr
About this study
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 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. The investigators would like to find out if giving amlodipine medication to people with late life non-responding vascular depression would be acceptable to this patient group. The investigators would also like to know how they feel while having the treatment and whether this provides a measurable benefit for those patients and whether those benefits are relevant to the patients. The investigators would also like to find out the information the investigators need to plan and prepare for a larger version of this study.
Read the detailed description
Depression has a high prevalence and causes other problems in older people. Two-thirds of these patients will not have an improvement in their condition from routine treatment. About hald 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 medications called Calcium Channel Blockers 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 late life non-responding vascular 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.
Participants may be eligible for the study if they are 50 years old or over, and have been diagnosed with depression which has not gotten better with other drugs, we call this type of depression 'Vascular Depression'.
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 for up to seven visits as part of this clinical trial, and would be required to take the study medication prescribed to them. The study medication may be either amlodipine or placebo, however 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 assigned to receiving either amlodipine or placebo in a process called randomisation.
As part of this study, participants will be invited to attend the unit mentioned above for their study visit, the first of which will be to discuss this study in further detail and allowing the participant time to ask any questions and to consider their participation in the study. 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 another visit, which will also be used to confirm the participants eligibility. At this visit the participant will be required to have a physical examination from the study doctor, have their blood pressure checked and complete the nine short questionnaires. Once a participant has been confirmed as eligible for the study, they will be entered into the study and randomised to receive either amlodipine or placebo. The participant will then receive four weeks supply of the study medication.
Two weeks after this visit, and again at 6 weeks and 12 weeks into the study, each participant will be contacted by the research study 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 will receive their next supply of study medication.
At 16 weeks after starting the study, 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 assessed, as well as a blood sample will be taken. 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 again, 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 in the main part of the study.
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 the small risk of bruising or infection at the site where the blood sample was taken. Other risks include the possible side effects of the study drug (amlodipine) which may include swelling of the ankles, dizziness, fatigue, nausea, indigestion, palpitations 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.
Potential participants will be identified at their GP practices which will be involved in the study as Participant Identification Centres (PICs).
The study is being sponsored by Gateshead Health NHS Foundation Trust, and is funded by the National Institute for Health Research - Research for Patient Benefit. The study will start around the 1st April 2012 and will run for approximately 24 months.
The main contact for any potential participant for this study will be Julie Henry (Research Nurse) based at the Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL, Telephone: 0191 248 1280 (reception)
- Conditions
- Depression
- Being tested
- Amlodipine, Placebo
- Keywords
- Late-life Unremitted Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Starting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo)
PlaceboDrug
Starting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo)
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine | Experimental | Not described Receives: Drug: Amlodipine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates to study invitation to GP practices and patients
To determine the response rates to study invitiation by GP practices (for involvement as a PIC) and patients (for study participation)
Measured: 24 months
Secondary outcomes (9)
HAM-D score of less than 10 for 2 consecutive assessments
To measure remission (HAM-D < 10 for 2 consecutive assessments) by 16 weeks of augmentation
Measured: 16 weeks
Ham-D reduction in symptoms
To review any reduction in symptoms over the 16 weeks treatment period as shown by the HAM-D questionnaire
Measured: 16 weeks
Geriatric Depression Scale questionnaire
to measure and record responses and changes reported on the GDS questionnaire over the course of treatment
Measured: 16 weeks
EQ-5D questionnaire
To review reponses and changes in responses to the EQ-5D over the course of 16 weeks of treatment
Measured: 16 weeks
Clinical Global Impression severity and improvement
The CGI questionnaires will be reviewed for severity and any improvement over the course of the 16 week treatment
Measured: 16 weeks
Instrumental Activities of Daily Living questionnaire
to review reponses and changes reported in the IADL questionnaire over the course of 16 weeks of treatment
Measured: 16 weeks
reduction in symptoms (HAM-D) in those with significant baseline white matter hyperintensities
To review any reduction in symptoms on the HAM-D questionnaire over the course of 16 weeks in participants with significant WMH as shown on MRI scan
Measured: 16 weeks
Blood pressure
To review blood presure in participants over the course of 16 weeks of treatment
Measured: 16 weeks
Effect of treatment on perfusion
to evaluate the effect of treatment on perfusion as determine by second MRI scan
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gateshead Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Alan Thomas, Dr, Principal investigator, Gateshead Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557153
- Sponsor's protocol ID
- 724
- Other IDs
- RfPB PB-PG-0609-19028, 2010-023969-21
- Acronym
- VALUeD
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Augmentation of Late-life Unremitted Depression (VALUeD)
- ClinicalTrials.gov ID
- NCT01557153
- Acronym / sponsor ID
- VALUeD / 724
- Conditions
- Depression
- Keywords
- Late-life Unremitted Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gateshead Health NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 19 Mar 2012 (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.
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 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. The investigators would like to find out if giving amlodipine medication to people with late life non-responding vascular depression would be acceptable to this patient group. The investigators would also like to know how they feel while having the treatment and whether this provides a measurable benefit for those patients and whether those benefits are relevant to the patients. The investigators would also like to find out the information the investigators need to plan and prepare for a larger version of this study.
Detailed description
Depression has a high prevalence and causes other problems in older people. Two-thirds of these patients will not have an improvement in their condition from routine treatment. About hald 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 medications called Calcium Channel Blockers 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 late life non-responding vascular 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.
Participants may be eligible for the study if they are 50 years old or over, and have been diagnosed with depression which has not gotten better with other drugs, we call this type of depression 'Vascular Depression'.
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 for up to seven visits as part of this clinical trial, and would be required to take the study medication prescribed to them. The study medication may be either amlodipine or placebo, however 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 assigned to receiving either amlodipine or placebo in a process called randomisation.
As part of this study, participants will be invited to attend the unit mentioned above for their study visit, the first of which will be to discuss this study in further detail and allowing the participant time to ask any questions and to consider their participation in the study. 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 another visit, which will also be used to confirm the participants eligibility. At this visit the participant will be required to have a physical examination from the study doctor, have their blood pressure checked and complete the nine short questionnaires. Once a participant has been confirmed as eligible for the study, they will be entered into the study and randomised to receive either amlodipine or placebo. The participant will then receive four weeks supply of the study medication.
Two weeks after this visit, and again at 6 weeks and 12 weeks into the study, each participant will be contacted by the research study 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 will receive their next supply of study medication.
At 16 weeks after starting the study, 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 assessed, as well as a blood sample will be taken. 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 again, 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 in the main part of the study.
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 the small risk of bruising or infection at the site where the blood sample was taken. Other risks include the possible side effects of the study drug (amlodipine) which may include swelling of the ankles, dizziness, fatigue, nausea, indigestion, palpitations 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.
Potential participants will be identified at their GP practices which will be involved in the study as Participant Identification Centres (PICs).
The study is being sponsored by Gateshead Health NHS Foundation Trust, and is funded by the National Institute for Health Research - Research for Patient Benefit. The study will start around the 1st April 2012 and will run for approximately 24 months.
The main contact for any potential participant for this study will be Julie Henry (Research Nurse) based at the Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL, Telephone: 0191 248 1280 (reception)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine | Experimental | Drug: Amlodipine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 years or more
- Clinically significant (unremitted) vascular depression, as defined above.
- MMSE > 23
- BP < 150/90 (QoF Audit standard)
- Patient has provided written informed consent for participation in the study prior to any study specific procedures
Key exclusion criteria (10 listed)
- Taking a calcium channel blocker
- Clinical evidence of dementia
- History or clinical evidence of stroke
- History of bipolar or psychotic disorder
- Significant suicide risk
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 |
|---|---|---|
| AmlodipineStarting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo) | Drug | Amlodipine |
| PlaceboStarting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo) | Drug | Placebo |
Primary outcome
Response rates to study invitation to GP practices and patients
Time frame: 24 months
To determine the response rates to study invitiation by GP practices (for involvement as a PIC) and patients (for study participation)
9 secondary outcomes
HAM-D score of less than 10 for 2 consecutive assessments
Time frame: 16 weeks
Ham-D reduction in symptoms
Time frame: 16 weeks
Geriatric Depression Scale questionnaire
Time frame: 16 weeks
EQ-5D questionnaire
Time frame: 16 weeks
Clinical Global Impression severity and improvement
Time frame: 16 weeks
Instrumental Activities of Daily Living questionnaire
Time frame: 16 weeks
reduction in symptoms (HAM-D) in those with significant baseline white matter hyperintensities
Time frame: 16 weeks
Blood pressure
Time frame: 16 weeks
Effect of treatment on perfusion
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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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.
Alan Thomas, Dr principal investigator
Gateshead Health NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine in people with Depression, run by Gateshead Health NHS Foundation Trust at 1 site 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 10 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alan Thomas, Dr (+44(0)1914455212, a.j.thomas@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rates to study invitation to GP practices and patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2012.