Vascular Augmentation of Late-life Unremitted Depression (VALUeD)
This study is not yet open for participant recruitment.
Verified March 2012 by Gateshead Health NHS Foundation Trust
Sponsor:
Gateshead Health NHS Foundation Trust
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Gateshead Health NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01557153
First received: March 13, 2012
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Amlodipine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vascular Augmentation of Late-life Unremitted Depression (VALUeD) |
Resource links provided by NLM:
Further study details as provided by Gateshead Health NHS Foundation Trust:
Primary Outcome Measures:
- Response rates to study invitation to GP practices and patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]To determine the response rates to study invitiation by GP practices (for involvement as a PIC) and patients (for study participation)
Secondary Outcome Measures:
- HAM-D score of less than 10 for 2 consecutive assessments [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To measure remission (HAM-D < 10 for 2 consecutive assessments) by 16 weeks of augmentation
- Ham-D reduction in symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To review any reduction in symptoms over the 16 weeks treatment period as shown by the HAM-D questionnaire
- Geriatric Depression Scale questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]to measure and record responses and changes reported on the GDS questionnaire over the course of treatment
- EQ-5D questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To review reponses and changes in responses to the EQ-5D over the course of 16 weeks of treatment
- Clinical Global Impression severity and improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The CGI questionnaires will be reviewed for severity and any improvement over the course of the 16 week treatment
- Instrumental Activities of Daily Living questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]to review reponses and changes reported in the IADL questionnaire over the course of 16 weeks of treatment
- reduction in symptoms (HAM-D) in those with significant baseline white matter hyperintensities [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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
- Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To review blood presure in participants over the course of 16 weeks of treatment
- Effect of treatment on perfusion [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]to evaluate the effect of treatment on perfusion as determine by second MRI scan
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Amlodipine |
Drug: Amlodipine
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)
|
| Placebo Comparator: Placebo |
Drug: Placebo
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)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557153
Contacts
| Contact: Alan Thomas, Dr | +44(0)1914455212 | a.j.thomas@ncl.ac.uk |
| Contact: Melinda Jeffels | +4490)1912227249 | melinda.jeffels@ncl.ac.uk |
Locations
| United Kingdom | |
| Clinical Ageing Research Unit | Not yet recruiting |
| Newcastle upon Tyne, United Kingdom, NE4 5PL | |
| Contact: Susan Atkinson +44(0)1912481267 susan.atkinson@ncl.ac.uk | |
| Principal Investigator: Alan Thomas, Dr | |
Sponsors and Collaborators
Gateshead Health NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
| Principal Investigator: | Alan Thomas, Dr | Gateshead Health NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Gateshead Health NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01557153 History of Changes |
| Other Study ID Numbers: | 724, RfPB PB-PG-0609-19028, 2010-023969-21 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee |
Keywords provided by Gateshead Health NHS Foundation Trust:
|
Late-life Unremitted Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Amlodipine Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 23, 2013