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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

    Summary
    EudraCT number
    2012-001950-25
    Trial protocol
    DE   FI   BG  
    Global end of trial date
    11 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Nov 2017
    First version publication date
    18 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VLZ-MD-02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01573598
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Forest Laboratories Inc, an Affilate of Allergan plc; Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    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 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the prevention of depression relapse in patients with major depressive disorder
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Apr 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
    Bulgaria: 5
    Country: Number of subjects enrolled
    Finland: 41
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Romania: 17
    Country: Number of subjects enrolled
    Serbia: 39
    Country: Number of subjects enrolled
    Ukraine: 15
    Country: Number of subjects enrolled
    United States: 384
    Worldwide total number of subjects
    563
    EEA total number of subjects
    125
    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)
    539
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The 1-2 week Screening/Wash-Out Phase was followed by the 8 week Run-In Phase of open-label treatment with vilazodone 40 mg/day. The Run-In phase included 1213 patients. The Run-In Phase was followed by the 12-week open-label Stabilization Phase; 879 patients entered the Stabilization Phase. Subsequently, 563 patients were randomized.

    Period 1
    Period 1 title
    Double-Blind (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for the first 4 days of Week 21, vilazodone 10 mg for the last 3 days of Week 21, and matched placebo capsules from Week 22 through Week 50.
    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
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for the first 4 days of Week 21, vilazodone 10 mg for the last 3 days of Week 21, and matched placebo capsules from Week 22 through Week 50.

    Arm title
    Vilazodone 20 mg
    Arm description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for Weeks 21 through 49, vilazodone 10 mg for Week 49, and matching placebo for Week 50.
    Arm type
    Experimental

    Investigational medicinal product name
    Vilazodone
    Investigational medicinal product code
    Other name
    Viibryd
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for Weeks 21 through 49, vilazodone 10 mg for Week 49, and matching placebo for Week 50.

    Arm title
    Vilazodone 40 mg
    Arm description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 to 48, vilazodone 20 mg for the first 4 days of Week 49, vilazodone 10 mg for the last 3 days of Week 49, and matching placebo for Week 50.
    Arm type
    Experimental

    Investigational medicinal product name
    Vilazodone
    Investigational medicinal product code
    Other name
    Viibryd
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 to 48, vilazodone 20 mg for the first 4 days of Week 49, vilazodone 10 mg for the last 3 days of Week 49, and matching placebo for Week 50.

    Number of subjects in period 1
    Placebo Vilazodone 20 mg Vilazodone 40 mg
    Started
    192
    185
    186
    Completed
    136
    119
    121
    Not completed
    56
    66
    65
         Consent withdrawn by subject
    17
    16
    9
         Adverse event, non-fatal
    2
    4
    1
         Other Reasons
    4
    4
    5
         Lost to follow-up
    3
    10
    11
         Relapse Event
    23
    20
    25
         Protocol deviation
    7
    12
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for the first 4 days of Week 21, vilazodone 10 mg for the last 3 days of Week 21, and matched placebo capsules from Week 22 through Week 50.

    Reporting group title
    Vilazodone 20 mg
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for Weeks 21 through 49, vilazodone 10 mg for Week 49, and matching placebo for Week 50.

    Reporting group title
    Vilazodone 40 mg
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 to 48, vilazodone 20 mg for the first 4 days of Week 49, vilazodone 10 mg for the last 3 days of Week 49, and matching placebo for Week 50.

    Reporting group values
    Placebo Vilazodone 20 mg Vilazodone 40 mg Total
    Number of subjects
    192 185 186 563
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    184 174 181 539
        From 65-84 years
    8 11 5 24
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    46.7 ( 11.9 ) 45.2 ( 12.6 ) 43.8 ( 12.0 ) -
    Gender categorical
    Units: Subjects
        Female
    116 113 126 355
        Male
    76 72 60 208

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for the first 4 days of Week 21, vilazodone 10 mg for the last 3 days of Week 21, and matched placebo capsules from Week 22 through Week 50.

    Reporting group title
    Vilazodone 20 mg
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 through 20, vilazodone 20 mg for Weeks 21 through 49, vilazodone 10 mg for Week 49, and matching placebo for Week 50.

    Reporting group title
    Vilazodone 40 mg
    Reporting group description
    Vilazodone 10 mg for Week 1, vilazodone 20 mg for Week 2, vilazodone 40 mg for Weeks 3 to 48, vilazodone 20 mg for the first 4 days of Week 49, vilazodone 10 mg for the last 3 days of Week 49, and matching placebo for Week 50.

    Primary: Time to First Relapse During the Double-Blind Treatment Phase (DBP)

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    End point title
    Time to First Relapse During the Double-Blind Treatment Phase (DBP) [1]
    End point description
    Relapse is defined as meeting any 1 or more of the following: 1) Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥ 18 and meeting criteria for a major depressive episode (MDE) per the MDE Checklist; 2) MADRS total score (from 0 [absence of symptoms] to 60 [maximum severity] ≥ 18 at 2 consecutive visits (where the second visit is in the 7-14 day period after the first visit); 3) Discontinuation for insufficient therapeutic response during the DBP. Insufficient therapeutic response is defined by: a) The inability to continue in the study due to worsening of depression, as determined by a need for change in pharmacological treatment and an increase in Clinical Global Impressions–Severity (CGI-S) score (from 0 [normal state] to 7 [among the most extremely ill] of ≥ 2 compared with that obtained at Week 20; b) Need for hospitalization due to worsening of depression.
    End point type
    Primary
    End point timeframe
    Randomization date (Week 20) to the relapse date, up to 28 weeks (Week 48)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point.
    End point values
    Placebo Vilazodone 20 mg Vilazodone 40 mg
    Number of subjects analysed
    190 [2]
    185 [3]
    186 [4]
    Units: Days
        median (confidence interval 95%)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
    Notes
    [2] - No differences between treatment groups; 999 represents N/A
    [3] - No differences between treatment groups; 999 represents N/A
    [4] - No differences between treatment groups; 999 represents N/A
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored from informed consent signature to the end of study for each subject.
    Adverse event reporting additional description
    The Run-In Phase (RIP) Safety Population consists of all screened pts who have a screening number, signed informed consent, and who took at least 1 dose of open-label vilazodone during the RIP of the study. The Double-blind (DB) Safety Population consists of all randomized pts who took at least 1 dose of DB investigational product.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo - Double Blind Phase
    Reporting group description
    Vilazodone 20 mg taken orally once per day the first 4 days of Week 21, vilazodone 10 mg for the last 3 days of Week 21, and matched placebo capsules taken orally once per day from Weeks 22 through Week 50.

    Reporting group title
    Vilazodone 40 mg - Double Blind Phase
    Reporting group description
    Vilazodone 40 mg taken orally once per day for Weeks 3 through 48, vilazodone 20 mg for the first 4 days of Week 49, vilazodone 10 mg for the last 3 days of Week 49, and matching placebo for Week 50.

    Reporting group title
    Vilazodone 20 mg - Double Blind Phase
    Reporting group description
    Vilazodone 20 mg taken orally once per day for Weeks 21 through 48, vilazodone 10 mg for Week 49, and matching placebo for Week 50.

    Serious adverse events
    Placebo - Double Blind Phase Vilazodone 40 mg - Double Blind Phase Vilazodone 20 mg - Double Blind Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 192 (2.08%)
    1 / 186 (0.54%)
    5 / 185 (2.70%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Urine output decreased
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Melaena
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 186 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 186 (0.54%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 186 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fibromyalgia
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 186 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo - Double Blind Phase Vilazodone 40 mg - Double Blind Phase Vilazodone 20 mg - Double Blind Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    103 / 192 (53.65%)
    115 / 186 (61.83%)
    101 / 185 (54.59%)
    Investigations
    Weight increased
         subjects affected / exposed
    4 / 192 (2.08%)
    10 / 186 (5.38%)
    7 / 185 (3.78%)
         occurrences all number
    4
    10
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 192 (4.69%)
    18 / 186 (9.68%)
    15 / 185 (8.11%)
         occurrences all number
    11
    26
    20
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 192 (4.69%)
    15 / 186 (8.06%)
    13 / 185 (7.03%)
         occurrences all number
    11
    16
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 192 (7.29%)
    15 / 186 (8.06%)
    16 / 185 (8.65%)
         occurrences all number
    16
    20
    19
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 192 (6.25%)
    10 / 186 (5.38%)
    12 / 185 (6.49%)
         occurrences all number
    16
    11
    13

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2012
    (1) add recurrent depression as an inclusion criteria; (2) change the inclusion MADRS score to 26; (3) add AE assessment at Visit 1; (4) allow for changes in MADRS scores during the Screening Period; (5) change the relapse criteria and add Major Depressive Episode Checklist; (6) add justification of the use of the placebo arm in relapse prevention; (7) revise 3 exclusion criteria; (8) delete a laboratory test from the Chemistry panel; (9) add washout language; (10) add the MADRS at every visit; (11) revise the efficacy analyses section to clarify relapse criteria; (12) add the description of the MMRM approach for analysis of additional efficacy parameters; (13) adjust the assumption on relapse event rates and recalculating the power of the study; (14) update Gastrointestinal and Sedatives/Hypnotics medications
    21 May 2013
    change the developmental phase of the trial for Non-US countries from Phase 4 to Phase 3
    27 Jan 2014
    (1) clarify the approximate number of planned enrolled patients; (2) revise the language in the introduction related to the IB version date and adverse reactions in previous trials; (3) correct a discrepancy regarding down-titration duration at the beginning of the DBP; (4) perform an administrative update to exclusion criteria to accommodate for Non-US sites; (5) clarify open-label down-taper language; (6) update the list of anti-insomnia agents; (7) clarify the definition of CGI-S and correct the training requirements; (8) update the relapse assumptions; (9) update hypnotics and antineoplastic medications
    29 Sep 2014
    (1) add the description of sensitivity analyses on the primary efficacy parameter in response to FDA statistical comments; (2) delete the protocol deviation section; (3) add a stratification factor of US/non-US category in the primary efficacy analysis based on a FDA statistical comment; (4) add summaries on exposure, concomitant medication, and safety parameters during RIP and SP combined based on RIP Safety Population; (5) modify protocol deviation language

    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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