VLZ-MD-23: A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT02436239
Collaborator
(none)
330
Enrollment
56
Locations
1
Arm
38.7
Actual Duration (Months)
5.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Actual Study Start Date :
May 2, 2015
Actual Primary Completion Date :
Jul 23, 2018
Actual Study Completion Date :
Jul 23, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Vilazodone

Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Names:
  • Viibryd
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) [Visit 1 (Week -1) to up to Visit 16 (Week 26)]

      The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period

    Secondary Outcome Measures

    1. Change From Baseline in the CDRS-R Total Score [Baseline (Week 0) to Week 26]

      The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

    2. Change From Baseline in the CGI-S Score [Baseline (Week 0) to Week 26]

      The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.

    3. Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) [Baseline (Week 0) to Week 26]

      The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or Female outpatients betw een 7-17 years of age

    • Primary diagnosis of major depressive disorder (MDD)

    • Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

    • Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

    Exclusion Criteria:
    • Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)

    • History of suicidal behavior, or requires precaution against suicide

    • Not generally healthy medical condition

    • Seizure disorder

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alliance Clinical ResearchBirminghamAlabamaUnited States35213
    2Harmonex Neuroscience ResearchDothanAlabamaUnited States36303
    3Phoenix Children's HospitalPhoenixArizonaUnited States85016
    4Woodland International Research Group, INCLittle RockArkansasUnited States72211
    5CITrials - BellflowerBellflowerCaliforniaUnited States90706
    6ATP Clinical ResearchCosta MesaCaliforniaUnited States92626
    7Behavioral Research Specialists, LLCGlendaleCaliforniaUnited States91206
    8PCSD - Feighner ResearchSan DiegoCaliforniaUnited States92108
    9Pacific Clinical Research Medical GroupHartfordConnecticutUnited States06106
    10Children's National Medical CenterWashingtonDistrict of ColumbiaUnited States20010
    11Palm Springs Research, LLCHialeahFloridaUnited States33012
    12IMIC Inc.HomesteadFloridaUnited States33030
    13Clinical Neuroscience Solutions, Inc.JacksonvilleFloridaUnited States32256
    14Innovative Clinical Research, Inc.LauderhillFloridaUnited States33319
    15Clinical Neuroscience Solutions, Inc.OrlandoFloridaUnited States32801
    16Institute for Advanced Medical ResearchAlpharettaGeorgiaUnited States30005
    17Atlantic Center for Medical ResearchAtlantaGeorgiaUnited States30331
    18Northwest Behavioral Research CenterMariettaGeorgiaUnited States30060
    19Capstone Clinical ResearchLibertyvilleIllinoisUnited States60048
    20Baber Research GroupNapervilleIllinoisUnited States60563
    21Neuroscience Research Institute Inc.Oak ParkIllinoisUnited States60301
    22Psychiatric AssociatesOverland ParkKansasUnited States66211
    23Lake Charles Clinical TrialsLake CharlesLouisianaUnited States70629
    24Hugo W Moser Research Institute at Kennedy Krieger, Inc.BaltimoreMarylandUnited States21205
    25Pharmsite Research Inc.BaltimoreMarylandUnited States21208
    26NeuroScientific InsightsRockvilleMarylandUnited States20852
    27Baystate Medical CenterSpringfieldMassachusettsUnited States01199
    28Adams Clinical Trials, LLCWatertownMassachusettsUnited States02472
    29Millennium Psychiatric AssociatesCreve CoeurMissouriUnited States63141
    30St. Charles Psychiatric Associates - Midwest Research GroupSaint CharlesMissouriUnited States63304
    31Erie County Medical Center/State University of New York of Buffalo AffiliateBuffaloNew YorkUnited States14215
    32BioScience Research LLCMount KiscoNew YorkUnited States10549
    33Manhattan Behavioral MedicineNew YorkNew YorkUnited States10022
    34Finger Lakes Clinical researchRochesterNew YorkUnited States14618
    35Richmond Behavioral AssociatesStaten IslandNew YorkUnited States10312
    36Haidar Almhana Nieding LLCAvon LakeOhioUnited States44012
    37Neuro-Behavioral Clinical Research, IncCantonOhioUnited States44718
    38University of CincinnatiCincinnatiOhioUnited States45219
    39University Hospitals Cleveland Medical Center, PsychiatrClevelandOhioUnited States44106
    40Ohio State Univ. Dept of PsychiatryColumbusOhioUnited States43210
    41Professional Psychiatric ServicesMasonOhioUnited States45040
    42IPS Research CompanyOklahoma CityOklahomaUnited States73103
    43Cutting Edge Research GroupOklahoma CityOklahomaUnited States73116
    44Research Strategies of Memphis LLCMemphisTennesseeUnited States38119
    45BioBehavioral Research of Austin, PCAustinTexasUnited States78759
    46UT Health Science Center at HoustonHoustonTexasUnited States77054
    47Houston Endoscopy and Research CtrHoustonTexasUnited States77079
    48Research Across AmericaPlanoTexasUnited States75093
    49Focus and BalanceSan AntonioTexasUnited States78229
    50Family Psychiatry of The WoodlandsThe WoodlandsTexasUnited States77381
    51Ericksen Research and DevelopmentClintonUtahUnited States84015
    52UVA Center for Psychopharmacology Research in YouthCharlottesvilleVirginiaUnited States22903
    53Northwest Clinical Research CenterBellevueWashingtonUnited States98007
    54Core Clinical ResearchKirklandWashingtonUnited States98033
    55Okanagan Clinical Trials Inc.KelownaBritish ColumbiaCanadaV1Y1Z9
    56Paediatric Sleep Research IncTorontoOntarioCanadaM6J3S3

    Sponsors and Collaborators

    • Forest Laboratories

    Investigators

    • Study Director: Emily McCusker, PhD, Forest Research Institute, Inc., an affiliate of Allergan, plc

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT02436239
    Other Study ID Numbers:
    • VLZ-MD-23
    First Posted:
    May 6, 2015
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Sep 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailPatients who completed lead-in study VLZ-MD-22 (NCT02372799) had already completed a down-taper period at the end of study VLZ-MD-22 and were not required to undergo a washout period in VLZ-MD-23. For de novo patients, the screening/washout period was generally 1 week prior to Baseline.
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    Period Title: Open-Lable Treatment Period
    STARTED1221316512
    COMPLETED8997387
    NOT COMPLETED3334275
    Period Title: Open-Lable Treatment Period
    STARTED90103446
    COMPLETED8699434
    NOT COMPLETED4412

    Baseline Characteristics

    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/VilazodoneTotal
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.Total of all reporting groups
    Overall Participants1221316512330
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    13.2
    (2.9)
    13.3
    (2.8)
    13.2
    (2.8)
    13.0
    (2.9)
    13.3
    (2.9)
    Age, Customized (Count of Participants)
    Age 7-11 Years
    37
    30.3%
    35
    26.7%
    19
    29.2%
    4
    33.3%
    95
    28.8%
    Age 12-17 Years
    83
    68%
    93
    71%
    46
    70.8%
    8
    66.7%
    230
    69.7%
    Age 18 Years
    2
    1.6%
    3
    2.3%
    0
    0%
    0
    0%
    5
    1.5%
    Sex: Female, Male (Count of Participants)
    Female
    68
    55.7%
    89
    67.9%
    33
    50.8%
    7
    58.3%
    197
    59.7%
    Male
    54
    44.3%
    42
    32.1%
    32
    49.2%
    5
    41.7%
    133
    40.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    16
    13.1%
    16
    12.2%
    8
    12.3%
    2
    16.7%
    42
    12.7%
    Not Hispanic or Latino
    106
    86.9%
    115
    87.8%
    57
    87.7%
    10
    83.3%
    288
    87.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    5
    4.1%
    1
    0.8%
    1
    1.5%
    0
    0%
    7
    2.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    2
    1.5%
    0
    0%
    0
    0%
    2
    0.6%
    Black or African American
    32
    26.2%
    40
    30.5%
    20
    30.8%
    1
    8.3%
    93
    28.2%
    White
    82
    67.2%
    84
    64.1%
    42
    64.6%
    11
    91.7%
    219
    66.4%
    More than one race
    3
    2.5%
    4
    3.1%
    2
    3.1%
    0
    0%
    9
    2.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    57.98
    (23.54)
    62.67
    (25.26)
    59.36
    (18.93)
    60.34
    (17.87)
    60.17
    (23.26)
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    22.73
    (6.59)
    24.75
    (7.96)
    23.30
    (5.37)
    23.90
    (6.20)
    23.69
    (6.98)
    CDRS-R total score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    55.7
    (9.6)
    59.3
    (9.5)
    57.8
    (8.7)
    59.7
    (9.1)
    58.4
    (9.3)
    CGI-S score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.6
    (0.6)
    4.7
    (0.7)
    4.6
    (0.6)
    4.2
    (0.4)
    4.6
    (0.6)

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
    DescriptionThe number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
    Time FrameVisit 1 (Week -1) to up to Visit 16 (Week 26)

    Outcome Measure Data

    Analysis Population Description
    The Safety Population consisted of the 330 participants who took at least 1 dose of open-label investigational product.
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    Measure Participants1221316512
    Count of Participants [Participants]
    90
    73.8%
    89
    67.9%
    48
    73.8%
    10
    83.3%
    2. Secondary Outcome
    TitleChange From Baseline in the CDRS-R Total Score
    DescriptionThe Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
    Time FrameBaseline (Week 0) to Week 26

    Outcome Measure Data

    Analysis Population Description
    The Change From Baseline in the CDRS-R Total Score was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    Measure Participants1211306311
    Mean (Standard Deviation) [units on a scale]
    -29.2
    (11.9)
    -30.1
    (12.2)
    -29.4
    (12.2)
    -24.5
    (10.3)
    3. Secondary Outcome
    TitleChange From Baseline in the CGI-S Score
    DescriptionThe Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
    Time FrameBaseline (Week 0) to Week 26

    Outcome Measure Data

    Analysis Population Description
    The CGI-S was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    Measure Participants1211306311
    Mean (Standard Deviation) [units on a scale]
    -2.5
    (1.3)
    -2.6
    (1.4)
    -2.5
    (1.4)
    -1.7
    (1.2)
    4. Secondary Outcome
    TitleChange From Baseline in Clinical Global Impressions-Improvement (CGI-I)
    DescriptionThe Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.
    Time FrameBaseline (Week 0) to Week 26

    Outcome Measure Data

    Analysis Population Description
    The CGI-I was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    Measure Participants1211306311
    Mean (Standard Deviation) [units on a scale]
    2.1
    (1.2)
    2.0
    (1.3)
    2.0
    (1.2)
    2.2
    (1.2)

    Adverse Events

    Time FrameAdverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
    Adverse Event Reporting Description
    Arm/Group TitlePlacebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Arm/Group DescriptionParticipants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.Newly enrolled participants received vilazodone tablets once daily, oral administration.
    All Cause Mortality
    Placebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/122 (0%) 0/131 (0%) 1/65 (1.5%) 0/12 (0%)
    Serious Adverse Events
    Placebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total6/122 (4.9%) 0/131 (0%) 1/65 (1.5%) 0/12 (0%)
    Infections and infestations
    Appendicitis1/122 (0.8%) 0/131 (0%) 0/65 (0%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Gun Shot Wound0/122 (0%) 0/131 (0%) 1/65 (1.5%) 0/12 (0%)
    Psychiatric disorders
    Suicidal ideation2/122 (1.6%) 0/131 (0%) 0/65 (0%) 0/12 (0%)
    Abnormal behaviour1/122 (0.8%) 0/131 (0%) 0/65 (0%) 0/12 (0%)
    Aggression1/122 (0.8%) 0/131 (0%) 0/65 (0%) 0/12 (0%)
    Suicide attempt1/122 (0.8%) 0/131 (0%) 0/65 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo/VilazodoneVilazodone/VilazodoneFluoxetine/VilazodoneDe Novo/Vilazodone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total79/122 (64.8%) 81/131 (61.8%) 41/65 (63.1%) 10/12 (83.3%)
    Ear and labyrinth disorders
    Ear Pain0/122 (0%) 1/131 (0.8%) 0/65 (0%) 2/12 (16.7%)
    Gastrointestinal disorders
    Nausea27/122 (22.1%) 16/131 (12.2%) 8/65 (12.3%) 2/12 (16.7%)
    Vomiting15/122 (12.3%) 8/131 (6.1%) 3/65 (4.6%) 0/12 (0%)
    Abdominal pain upper12/122 (9.8%) 6/131 (4.6%) 4/65 (6.2%) 0/12 (0%)
    Infections and infestations
    Nasopharyngitis5/122 (4.1%) 11/131 (8.4%) 2/65 (3.1%) 0/12 (0%)
    Gastroenteritis6/122 (4.9%) 3/131 (2.3%) 3/65 (4.6%) 1/12 (8.3%)
    Sinusitis1/122 (0.8%) 5/131 (3.8%) 2/65 (3.1%) 1/12 (8.3%)
    Investigations
    Weight increased7/122 (5.7%) 15/131 (11.5%) 4/65 (6.2%) 1/12 (8.3%)
    Nervous system disorders
    Headache21/122 (17.2%) 28/131 (21.4%) 8/65 (12.3%) 2/12 (16.7%)
    Dizziness3/122 (2.5%) 9/131 (6.9%) 4/65 (6.2%) 0/12 (0%)
    Migraine3/122 (2.5%) 3/131 (2.3%) 1/65 (1.5%) 1/12 (8.3%)
    Syncope0/122 (0%) 0/131 (0%) 0/65 (0%) 2/12 (16.7%)
    Amnesia0/122 (0%) 0/131 (0%) 0/65 (0%) 1/12 (8.3%)
    Psychiatric disorders
    Insomnia13/122 (10.7%) 11/131 (8.4%) 2/65 (3.1%) 0/12 (0%)
    Irritability4/122 (3.3%) 3/131 (2.3%) 0/65 (0%) 1/12 (8.3%)
    Agitation0/122 (0%) 2/131 (1.5%) 0/65 (0%) 1/12 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Dysmenorrhea3/122 (2.5%) 4/131 (3.1%) 3/65 (4.6%) 0/12 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    All data generated in this study are the property of the sponsor. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the sponsor and will follow sponsor's standard operating procedures on publications.

    Results Point of Contact

    Name/TitleArmin Szegedi, MD, PhD, Vice President CNS Clinical Development
    OrganizationAllergan
    Phone714-246-4500
    EmailIR-CTRegistration@allergan.com
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT02436239
    Other Study ID Numbers:
    • VLZ-MD-23
    First Posted:
    May 6, 2015
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Sep 1, 2019