NCT01557153

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 13, 2012

Last Update Submit

March 16, 2012

Conditions

Depression

Keywords

Late-life Unremitted Depression

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 months

Secondary Outcomes (9)

  • HAM-D score of less than 10 for 2 consecutive assessments

    16 weeks

  • Ham-D reduction in symptoms

    16 weeks

  • Geriatric Depression Scale questionnaire

    16 weeks

  • EQ-5D questionnaire

    16 weeks

  • Clinical Global Impression severity and improvement

    16 weeks

  • +4 more secondary outcomes

Study Arms (2)

Amlodipine

EXPERIMENTAL
Drug: Amlodipine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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)

Amlodipine
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)

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Ageing Research Unit

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

MeSH Terms

Conditions

Depression

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alan Thomas, Dr

    Gateshead Health NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Thomas, Dr

CONTACT

+44(0)1914455212a.j.thomas@ncl.ac.uk

Melinda Jeffels

CONTACT

+4490)1912227249melinda.jeffels@ncl.ac.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 19, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

GB(1)