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

Vascular Augmentation of Late-life Unremitted Depression - VALUeD, version 1.0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023969-21-GB

Enrollment

Registered

2011-09-21

Start date

2011-10-28

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-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

Interventions

Trade Name: Amlodipine 5mg Product Name: Amlodipine Pharmaceutical Form: INN or Proposed INN: AMLODIPINE (AMLODIPINE BESYLATE) CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 50 years or older Clinically significant (unremitted) vascular depression, as defined above. MMSE >23 Medically stable BP =65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026