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A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT00644358
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: vilazodone
Enrollment 616
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vilazodone
Hide Arm/Group Description Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.
Period Title: Overall Study
Started 616
Completed 254
Not Completed 362
Reason Not Completed
Adverse Event             124
Lost to Follow-up             105
Consent Withdrawal             64
Lack of Effectiveness             39
Protocol Violation             5
Noncompliance             14
Other Unspecified             11
Arm/Group Title Vilazodone
Hide Arm/Group Description Vilazodone titrated up to 40 mg/day for 1 year.
Overall Number of Baseline Participants 599
Hide Baseline Analysis Population Description
Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 599 participants
42.8  (12.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants
Female
407
  67.9%
Male
192
  32.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants
Hispanic or Latino
54
   9.0%
Not Hispanic or Latino
545
  91.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants
American Indian or Alaska Native
3
   0.5%
Asian
10
   1.7%
Native Hawaiian or Other Pacific Islander
3
   0.5%
Black or African American
103
  17.2%
White
479
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.2%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 599 participants
168.4  (9.62)
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time Frame From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.
Arm/Group Title Vilazodone
Hide Arm/Group Description:
Vilazodone titrated up to 40 mg/day for 1 year.
Overall Number of Participants Analyzed 599
Measure Type: Number
Unit of Measure: Participants
562
2.Secondary Outcome
Title Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Hide Description The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Time Frame Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.
Arm/Group Title Vilazodone
Hide Arm/Group Description:
Vilazodone titrated up to 40 mg/day for 1 year.
Overall Number of Participants Analyzed 596
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 29.9  (4.45)
Change from Baseline at Week 1 -4.7  (5.38)
Change from Baseline at Week 2 -9.3  (6.72)
Change from Baseline at Week 3 -13.0  (7.76)
Change from Baseline at Week 4 -14.9  (7.99)
Change from Baseline at Week 6 -17.1  (8.28)
Change from Baseline at Week 8 -18.5  (8.38)
Change from Baseline at Week 12 -19.9  (8.31)
Change from Baseline at Week 16 -20.6  (8.31)
Change from Baseline at Week 20 -21.1  (8.39)
Change from Baseline at Week 24 -21.7  (7.81)
Change from Baseline at Week 28 -21.6  (7.99)
Change from Baseline at Week 32 -21.9  (8.26)
Change from Baseline at Week 36 -22.1  (7.89)
Change from Baseline at Week 40 -22.7  (7.33)
Change from Baseline at Week 44 -21.9  (8.12)
Change from Baseline at Week 48 -22.5  (7.92)
Change from Baseline at Week 52 -22.8  (7.89)
Change from Baseline at Early Termination -10.9  (9.78)
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score
Hide Description The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.
Time Frame Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.
Arm/Group Title Vilazodone
Hide Arm/Group Description:
Vilazodone titrated up to 40 mg/day for 1 year.
Overall Number of Participants Analyzed 596
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.3  (0.52)
Change from Baseline at Week 1 -0.3  (0.57)
Change from Baseline at Week 2 -0.7  (0.83)
Change from Baseline at Week 3 -1.1  (1.04)
Change from Baseline at Week 4 -1.4  (1.12)
Change from Baseline at Week 6 -1.7  (1.18)
Change from Baseline at Week 8 -1.9  (1.21)
Change from Baseline at Week 12 -2.1  (1.18)
Change from Baseline at Week 16 -2.3  (1.13)
Change from Baseline at Week 20 -2.4  (1.15)
Change from Baseline at Week 24 -2.4  (1.09)
Change from Baseline at Week 28 -2.4  (1.09)
Change from Baseline at Week 32 -2.5  (1.11)
Change from Baseline at Week 36 -2.5  (1.13)
Change from Baseline at Week 40 -2.5  (1.05)
Change from Baseline at Week 44 -2.4  (1.12)
Change from Baseline at Week 48 -2.5  (1.08)
Change from Baseline at Week 52 -2.6  (1.13)
Change from Baseline at Early Termination -1.0  (1.21)
4.Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I) Score
Hide Description The CGI-I is a clinician-rated scale for assessing improvement of a patient’s condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.
Time Frame Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.
Arm/Group Title Vilazodone
Hide Arm/Group Description:
Vilazodone titrated up to 40 mg/day for 1 year.
Overall Number of Participants Analyzed 596
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 1 3.5  (0.67)
Week 2 3.0  (0.85)
Week 3 2.5  (0.94)
Week 4 2.3  (0.94)
Week 6 2.0  (0.92)
Week 8 1.9  (0.93)
Week 12 1.7  (0.93)
Week 16 1.6  (0.90)
Week 20 1.5  (0.84)
Week 24 1.5  (0.75)
Week 28 1.5  (0.79)
Week 32 1.5  (0.83)
Week 36 1.5  (0.78)
Week 40 1.4  (0.74)
Week 44 1.5  (0.86)
Week 48 1.4  (0.74)
Week 52 1.4  (0.75)
Early Termination 2.9  (1.18)
Time Frame From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vilazodone
Hide Arm/Group Description Vilazodone titrated up to 40 mg/day for 1 year.
All-Cause Mortality
Vilazodone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vilazodone
Affected / at Risk (%)
Total   23/599 (3.84%) 
Gastrointestinal disorders   
Duodenal stenosis  1  1/599 (0.17%) 
General disorders   
Chest discomfort  1  1/599 (0.17%) 
Chest pain  1  1/599 (0.17%) 
Pyrexia  1  1/599 (0.17%) 
Hepatobiliary disorders   
Cholecystitis  1  1/599 (0.17%) 
Gallbladder disorder  1  1/599 (0.17%) 
Infections and infestations   
Abdominal wall abscess  1  1/599 (0.17%) 
Enterocolitis infectious  1  1/599 (0.17%) 
Gastroenteritis  1  1/599 (0.17%) 
Pneumonia  1  2/599 (0.33%) 
Injury, poisoning and procedural complications   
Overdose  1  1/599 (0.17%) 
Skin laceration  1  1/599 (0.17%) 
Investigations   
Bronchoscopy  1  1/599 (0.17%) 
Metabolism and nutrition disorders   
Dehydration  1  1/599 (0.17%) 
Hypokalaemia  1  1/599 (0.17%) 
Hyponatraemia  1  1/599 (0.17%) 
Obesity  1  1/599 (0.17%) 
Nervous system disorders   
Serotonin syndrome  1  1/599 (0.17%) 
Syncope  1  1/599 (0.17%) 
Transient ischaemic attack  1  1/599 (0.17%) 
Pregnancy, puerperium and perinatal conditions   
Ruptured ectopic pregnancy  1  1/599 (0.17%) 
Psychiatric disorders   
Panic attack  1  1/599 (0.17%) 
Suicidal ideation  1  1/599 (0.17%) 
Suicide attempt  1  1/599 (0.17%) 
Renal and urinary disorders   
Renal failure acute  1  1/599 (0.17%) 
Reproductive system and breast disorders   
Endometriosis  1  1/599 (0.17%) 
Menometrorrhagia  1  1/599 (0.17%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/599 (0.17%) 
Chronic obstructive pulmonary disease  1  1/599 (0.17%) 
Pulmonary embolism  1  1/599 (0.17%) 
Sleep apnoea syndrome  1  1/599 (0.17%) 
Vascular disorders   
Deep vein thrombosis  1  1/599 (0.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vilazodone
Affected / at Risk (%)
Total   497/599 (82.97%) 
Gastrointestinal disorders   
Diarrhoea  1  214/599 (35.73%) 
Dry mouth  1  66/599 (11.02%) 
Nausea  1  189/599 (31.55%) 
Vomiting  1  44/599 (7.35%) 
General disorders   
Fatigue  1  46/599 (7.68%) 
Infections and infestations   
Nasopharyngitis  1  45/599 (7.51%) 
Upper respiratory tract infection  1  82/599 (13.69%) 
Urinary tract infection  1  35/599 (5.84%) 
Investigations   
Weight increased  1  57/599 (9.52%) 
Metabolism and nutrition disorders   
Increased appetite  1  54/599 (9.02%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  33/599 (5.51%) 
Nervous system disorders   
Dizziness  1  64/599 (10.68%) 
Headache  1  120/599 (20.03%) 
Somnolence  1  64/599 (10.68%) 
Psychiatric disorders   
Abnormal dreams  1  62/599 (10.35%) 
Anxiety  1  36/599 (6.01%) 
Insomnia  1  78/599 (13.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 1-877-277-8566
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00644358     History of Changes
Other Study ID Numbers: CLDA-07-DP-04
First Submitted: March 20, 2008
First Posted: March 26, 2008
Results First Submitted: August 22, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017