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Trial record 1 of 1 for:    NCT02436239
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A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)

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ClinicalTrials.gov Identifier: NCT02436239
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
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 330
Recruitment Details  
Pre-assignment Details Patients 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 Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description Participants 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
Started 122 131 65 12
Completed 89 97 38 7
Not Completed 33 34 27 5
Reason Not Completed
Adverse Event             12             3             4             2
Lack of Efficacy             1             6             6             1
Withdrawal by Subject             10             15             9             0
Lost to Follow-up             4             2             4             1
Protocol Violation             0             1             1             0
Noncompliance with Study Drug             5             6             3             1
Other Reason             1             1             0             0
Period Title: Down-Taper Period
Started 90 [1] 103 [1] 44 [1] 6 [2]
Completed 86 99 43 4
Not Completed 4 4 1 2
Reason Not Completed
Withdrawal by Subject             4             4             1             2
[1]
Enrollment permitted for participants who had not completed previous open-label treatment period.
[2]
One participant who completed the open-label treatment period did not enter the down-taper period.
Arm/Group Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone Total
Hide Arm/Group Description Participants 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 Number of Baseline Participants 122 131 65 12 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 participants
13.2  (2.9) 13.3  (2.8) 13.2  (2.8) 13.0  (2.9) 13.3  (2.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 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
  68.0%
93
  71.0%
46
  70.8%
8
  66.7%
230
  69.7%
Age 18 Years
2
   1.6%
3
   2.3%
0
   0.0%
0
   0.0%
5
   1.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 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
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   4.1%
1
   0.8%
1
   1.5%
0
   0.0%
7
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.5%
0
   0.0%
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
   0.0%
9
   2.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 participants
57.98  (23.54) 62.67  (25.26) 59.36  (18.93) 60.34  (17.87) 60.17  (23.26)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 122 participants 131 participants 65 participants 12 participants 330 participants
22.73  (6.59) 24.75  (7.96) 23.30  (5.37) 23.90  (6.20) 23.69  (6.98)
CDRS-R total score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 121 participants 130 participants 63 participants 11 participants 325 participants
55.7  (9.6) 59.3  (9.5) 57.8  (8.7) 59.7  (9.1) 58.4  (9.3)
[1]
Measure Description: 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]
Measure Analysis Population Description: The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
CGI-S score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 121 participants 130 participants 63 participants 11 participants 325 participants
4.6  (0.6) 4.7  (0.7) 4.6  (0.6) 4.2  (0.4) 4.6  (0.6)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
1.Primary Outcome
Title Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
Hide Description 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
Time Frame Visit 1 (Week -1) to up to Visit 16 (Week 26)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of the 330 participants who took at least 1 dose of open-label investigational product.
Arm/Group Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 122 131 65 12
Measure Type: Count of Participants
Unit of Measure: Participants
90
  73.8%
89
  67.9%
48
  73.8%
10
  83.3%
2.Secondary Outcome
Title Change From Baseline in the CDRS-R Total Score
Hide Description 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.
Time Frame Baseline (Week 0) to Week 26
Hide Outcome Measure Data
Hide 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 Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 121 130 63 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-29.2  (11.9) -30.1  (12.2) -29.4  (12.2) -24.5  (10.3)
3.Secondary Outcome
Title Change From Baseline in the CGI-S Score
Hide Description 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.
Time Frame Baseline (Week 0) to Week 26
Hide Outcome Measure Data
Hide 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 Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 121 130 63 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (1.3) -2.6  (1.4) -2.5  (1.4) -1.7  (1.2)
4.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
Hide Description 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.
Time Frame Baseline (Week 0) to Week 26
Hide Outcome Measure Data
Hide 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 Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 121 130 63 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (1.2) 2.0  (1.3) 2.0  (1.2) 2.2  (1.2)
Time Frame Adverse 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 [Not Specified]
 
Arm/Group Title Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Hide Arm/Group Description Participants 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/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/131 (0.00%)   1/65 (1.54%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/122 (4.92%)   0/131 (0.00%)   1/65 (1.54%)   0/12 (0.00%) 
Infections and infestations         
Appendicitis  1  1/122 (0.82%)  0/131 (0.00%)  0/65 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Gun Shot Wound  1  0/122 (0.00%)  0/131 (0.00%)  1/65 (1.54%)  0/12 (0.00%) 
Psychiatric disorders         
Suicidal ideation  1  2/122 (1.64%)  0/131 (0.00%)  0/65 (0.00%)  0/12 (0.00%) 
Abnormal behaviour  1  1/122 (0.82%)  0/131 (0.00%)  0/65 (0.00%)  0/12 (0.00%) 
Aggression  1  1/122 (0.82%)  0/131 (0.00%)  0/65 (0.00%)  0/12 (0.00%) 
Suicide attempt  1  1/122 (0.82%)  0/131 (0.00%)  0/65 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo/Vilazodone Vilazodone/Vilazodone Fluoxetine/Vilazodone De Novo/Vilazodone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   79/122 (64.75%)   81/131 (61.83%)   41/65 (63.08%)   10/12 (83.33%) 
Ear and labyrinth disorders         
Ear Pain  1  0/122 (0.00%)  1/131 (0.76%)  0/65 (0.00%)  2/12 (16.67%) 
Gastrointestinal disorders         
Nausea  1  27/122 (22.13%)  16/131 (12.21%)  8/65 (12.31%)  2/12 (16.67%) 
Vomiting  1  15/122 (12.30%)  8/131 (6.11%)  3/65 (4.62%)  0/12 (0.00%) 
Abdominal pain upper  1  12/122 (9.84%)  6/131 (4.58%)  4/65 (6.15%)  0/12 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  5/122 (4.10%)  11/131 (8.40%)  2/65 (3.08%)  0/12 (0.00%) 
Gastroenteritis  1  6/122 (4.92%)  3/131 (2.29%)  3/65 (4.62%)  1/12 (8.33%) 
Sinusitis  1  1/122 (0.82%)  5/131 (3.82%)  2/65 (3.08%)  1/12 (8.33%) 
Investigations         
Weight increased  1  7/122 (5.74%)  15/131 (11.45%)  4/65 (6.15%)  1/12 (8.33%) 
Nervous system disorders         
Headache  1  21/122 (17.21%)  28/131 (21.37%)  8/65 (12.31%)  2/12 (16.67%) 
Dizziness  1  3/122 (2.46%)  9/131 (6.87%)  4/65 (6.15%)  0/12 (0.00%) 
Migraine  1  3/122 (2.46%)  3/131 (2.29%)  1/65 (1.54%)  1/12 (8.33%) 
Syncope  1  0/122 (0.00%)  0/131 (0.00%)  0/65 (0.00%)  2/12 (16.67%) 
Amnesia  1  0/122 (0.00%)  0/131 (0.00%)  0/65 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Insomnia  1  13/122 (10.66%)  11/131 (8.40%)  2/65 (3.08%)  0/12 (0.00%) 
Irritability  1  4/122 (3.28%)  3/131 (2.29%)  0/65 (0.00%)  1/12 (8.33%) 
Agitation  1  0/122 (0.00%)  2/131 (1.53%)  0/65 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Dysmenorrhea  1  3/122 (2.46%)  4/131 (3.05%)  3/65 (4.62%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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.
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
Layout table for Results Point of Contact information
Name/Title: Armin Szegedi, MD, PhD, Vice President CNS Clinical Development
Organization: Allergan
Phone: 714-246-4500
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02436239     History of Changes
Other Study ID Numbers: VLZ-MD-23
First Submitted: April 28, 2015
First Posted: May 6, 2015
Results First Submitted: July 23, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019