Vascular Augmentation of Late-life Unremitted Depression (VALUeD)
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Response rates to study invitation to GP practices and patients
Study Overview
Brief 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'. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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)
Arms & Interventions
Amlodipine
Intervention: Amlodipine (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Ham-D reduction in symptoms(16 weeks)
- Geriatric Depression Scale questionnaire(16 weeks)
- HAM-D score of less than 10 for 2 consecutive assessments(16 weeks)
- Instrumental Activities of Daily Living questionnaire(16 weeks)
- EQ-5D questionnaire(16 weeks)
- Clinical Global Impression severity and improvement(16 weeks)
- Effect of treatment on perfusion(16 weeks)
- reduction in symptoms (HAM-D) in those with significant baseline white matter hyperintensities(16 weeks)
- Blood pressure(16 weeks)