Adding a medication, amlodipine, to the treatment of older people with a type of depression that has not responded to previous treatment.

Phase 1

• Conditions: ate-life (aged 50 or over) unremitted vascular depression.; MedDRA version: 14.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-023969-21-GB
• Lead Sponsor: Gateshead Health NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2014-04-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Age 50 years or older Clinically significant (unremitted) vascular depression, as defined above. MMSE >23 Medically stable BP < 150/90 (Quality and Outcomes Framework Audit standard) Patient has provided written informed consent for participation in the study prior to any study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

On calcium channel blocker Clinical evidence of dementia History or evidence of stroke History of bipolar or psychotic disorder Significant suicide risk Known hypersensitivity to amlodipine 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) Previous participation in this study OPTIONAL MRI Sub Study only - Contraindications for MRI scanning (eg pacemaker in situ, metal fragments in eyes, or unwillingness to undergo MRI scanning)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide estimates of the effectiveness of the study medication, amlodipine, to inform a calculation for a larger more definitive study. We hypothesise that the amlodipine addition (augmentation) to a patients routine treatment will lead to significantly more people achieving remission (a lessening of their symptoms) at 16 weeks when compared with those patients who have the placebo augmentation. This is however a pilot study and as such is not expected to have sufficient numbers of participants to provide definitive proof of this.;Secondary Objective: To demonstrate we can identify and recruit sufficient numbers of older people with depression from primary care. To use a qualitative sub-study to assess the validity and relevance to patients of the outcome measures used.;Primary end point(s): The primary outcome measure is presence of remission (HAM-D<10 for 2 consecutive weeks) by 16 weeks of augmentation.;Timepoint(s) of evaluation of this end point: 16 weeks of augmentation