Vascular Augmentation of Late-life Unremitted Depression (VALUeD)

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gateshead Health NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom; Newcastle-upon-Tyne Hospitals NHS Trust
• Treatments: Amlodipine

Criteria

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)