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    Clinical Trial Results:
    Vascular Augmentation of Late-life Unremitted Depression

    Summary
    EudraCT number
    		 2010-023969-21
    Trial protocol
    		 GB  
    Global end of trial date
    15 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2019
    First version publication date
    11 Jul 2019
    Other versions
    Summary report(s)
    		 VALUeD Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    724
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gateshead Health NHS Foundation Trust
    Sponsor organisation address
    Sheriff Hill, Gateshead, United Kingdom, NE9 6SX
    Public contact
    Professor Alan J Thomas, Institute of Ageing & Health Campus for Ageing & Vitality Newcastle upon Tyne NE4 5PL, 0191 4455212, alan.thomas@newcastle.ac.uk
    Scientific contact
    Professor Alan J Thomas, Institute of Ageing & Health Campus for Ageing & Vitality Newcastle upon Tyne NE4 5P, 0191 4455212, alan.thomas@newcastle.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The questionnaires and instruments used for this study asked questions of the patient that could be upsetting by their very nature of asking questions about the patient’s mental state, feelings of guilt, cognition, hallucinations, thoughts of suicide, sexual performance and the impact of the patient’s depression and its possible affects on their daily lives. While all of this information is requested to permit a full understanding of the disease and to permit a measure if there are differences between the arms of this study, it is possible that the patient could become upset by the questions and their answers. The staff working on the study are experienced members of the research team with a great understanding of the disease and how it affects the patients’. Every care was taken to explain the requirements of the questionnaires and their importance while being sensitive and supportive to the patient and the carer. Support was provided through routine care in line with local policy to manage any particular concern that could be raised during the course of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were identified by searching Quality Outcome Framework long term illness databases for people over 50 who were on antidepressant medication, which shows that patients have been assessed as having a depressive illness which needs more than watchful waiting or counselling.

    Pre-assignment
    Screening details
    		 Potential participants were identified by screening computerised records in primary care, and secondary care. Local primary care practices were identified in Newcastle and Gateshead through the PCRN and NTW CLRN. Staff at these practices conducted computerised screening and sent out letters to potential study subjects using support from the PCRN/CL

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) web-based system in a 1:1 ratio stratified by severity (defined by a dichotomous variable indicating whether baseline HAM-D was less than or greater than or equal to 15) and the treatment allocation was kept blind from the subjects and the study assessors and investigators until study completion.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amlodipine
    Arm description
    		 This was a pilot and feasibility study to assess whether a large scale randomised controlled trial of augmentation treatment with the calcium channel blocker amlodipine would be feasible and acceptable in vascular depression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amlodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    Active and placebo study medication was provided as a 4 week initial supply of 5mg capsules followed by total of 12 week’s supply of 10mg, dispensed at week 4 and week 8.

    Arm title
    		 Placebo
    Arm description
    		 This was a pilot and feasibility study to assess whether a large scale randomised controlled trial of augmentation treatment with the calcium channel blocker amlodipine would be feasible and acceptable in vascular depression.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Active and placebo study medication was provided as a 4 week initial supply of 5mg capsules followed by total of 12 week’s supply of 10mg, dispensed at week 4 and week 8.

    Number of subjects in period 1
    		Amlodipine Placebo
    Started
    4
    4
    Completed
    4
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Amlodipine
    Reporting group description
    		 This was a pilot and feasibility study to assess whether a large scale randomised controlled trial of augmentation treatment with the calcium channel blocker amlodipine would be feasible and acceptable in vascular depression.

    Reporting group title
    Placebo
    Reporting group description
    		 This was a pilot and feasibility study to assess whether a large scale randomised controlled trial of augmentation treatment with the calcium channel blocker amlodipine would be feasible and acceptable in vascular depression.

    Primary: Determine response rates to study invitation to GP practices and patients

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    End point title
    		 Determine response rates to study invitation to GP practices and patients
    End point description
    End point type
    Primary
    End point timeframe
    Measure remission (Hamilton Rating Scale for Depression (HAM-D)<10 for 2 consecutive assessments) by 16 weeks of augmentation
    End point values
    		 Amlodipine Placebo
    Number of subjects analysed
    4
    4
    Units: Measure remission (Hamilton Rating Scale
        number (not applicable)
    4
    4
    Statistical analysis title
    		 Summary Statistics
    Statistical analysis description
    In total, of the 206 invited patients, 8 were recruited into the study. Rate = 8/206 = 3.9% (95% CI: 1.7 to 7.5%). As a result of this small sample size the analysis plan was altered from that described in the protocol. There was no comparative hypothesis testing and instead summary statistics were calculated for pre-specified outcome variables by arm. Study compliance was assessed in both group as well as remission rates. None of the patients achieved remission at any point in the study.
    Comparison groups
    Amlodipine v Placebo
    Number of subjects included in analysis
    8
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 > 0 [2]
    Method
    		 N/A
    Parameter type
    		 Confidence Intervals
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 11.58
    Variability estimate
    Standard deviation
    Notes
    [1] - This analysis is descriptive only. As a result of the achieved sample size no statistical comparison has been made between the trial arms.
    [2] - No P value obtained due to small sample size

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Any serious adverse events will be recorded throughout the duration of the trial until 1 week after trial therapy is stopped
    Adverse event reporting additional description
    No serious adverse events were reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only small sample size achieved.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2013
    Extra exclusion criteria
    04 Jul 2013
    Amendment 10 was a change to the exit strategy. Following a meeting of the DMEC, the committee agreed that unblinding the patients prior to study completion and data analysis may cause bias within the study due to associated unblinding of study staff. Unfortunately an internal error within CSP caused a delay in this amendment being approved by the Newcastle upon Tyne Hospitals NHS Foundation Trust. By the time that the approval came through, all patients had completed the trial and therefore consented to the earlier version of the PIS. 5 of the 8 participants requested to be unblinded in total.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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