Trial record 1 of 1 for:
NCT02436239
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
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Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Major Depressive Disorder |
Intervention |
Drug: Vilazodone |
Enrollment | 330 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Placebo/Vilazodone | Vilazodone/Vilazodone | Fluoxetine/Vilazodone | De Novo/Vilazodone | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 122 participants | 131 participants | 65 participants | 12 participants | 330 participants | |
Age 7-11 Years |
37 30.3%
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35 26.7%
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19 29.2%
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4 33.3%
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95 28.8%
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Age 12-17 Years |
83 68.0%
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93 71.0%
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46 70.8%
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8 66.7%
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230 69.7%
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Age 18 Years |
2 1.6%
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3 2.3%
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0 0.0%
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0 0.0%
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5 1.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 122 participants | 131 participants | 65 participants | 12 participants | 330 participants | |
Female |
68 55.7%
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89 67.9%
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33 50.8%
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7 58.3%
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197 59.7%
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Male |
54 44.3%
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42 32.1%
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32 49.2%
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5 41.7%
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133 40.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 122 participants | 131 participants | 65 participants | 12 participants | 330 participants | |
Hispanic or Latino |
16 13.1%
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16 12.2%
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8 12.3%
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2 16.7%
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42 12.7%
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Not Hispanic or Latino |
106 86.9%
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115 87.8%
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57 87.7%
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10 83.3%
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288 87.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 122 participants | 131 participants | 65 participants | 12 participants | 330 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
5 4.1%
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1 0.8%
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1 1.5%
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0 0.0%
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7 2.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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2 1.5%
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0 0.0%
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0 0.0%
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2 0.6%
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Black or African American |
32 26.2%
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40 30.5%
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20 30.8%
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1 8.3%
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93 28.2%
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White |
82 67.2%
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84 64.1%
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42 64.6%
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11 91.7%
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219 66.4%
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More than one race |
3 2.5%
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4 3.1%
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2 3.1%
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0 0.0%
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9 2.7%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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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 |
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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 |
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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.
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CGI-S score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Armin Szegedi, MD, PhD, Vice President CNS Clinical Development |
Organization: | Allergan |
Phone: | 714-246-4500 |
EMail: | IR-CTRegistration@allergan.com |
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT02436239 |
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 |