Vascular Augmentation of Late-life Unremitted Depressio

Phase 3

Completed

• Conditions: Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN46911260
• Lead Sponsor: Gateshead Health NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-31
• Study Completion: 2013-12-02
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified