A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-23)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | April 28, 2015 | |||
First Posted Date ICMJE | May 6, 2015 | |||
Results First Submitted Date ICMJE | July 23, 2019 | |||
Results First Posted Date ICMJE | September 11, 2019 | |||
Last Update Posted Date | September 11, 2019 | |||
Actual Study Start Date ICMJE | May 2, 2015 | |||
Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: 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
|
|||
Original Primary Outcome Measures ICMJE |
Number of patients to experience a Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 26 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder | |||
Official Title ICMJE | An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder | |||
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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: Vilazodone
Vilazodone tablets, once daily, oral administration
Other Name: Viibryd
|
|||
Study Arms ICMJE | Experimental: Vilazodone
Intervention: Drug: Vilazodone
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
330 | |||
Original Estimated Enrollment ICMJE |
250 | |||
Actual Study Completion Date ICMJE | July 23, 2018 | |||
Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 7 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02436239 | |||
Other Study ID Numbers ICMJE | VLZ-MD-23 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Forest Laboratories | |||
Study Sponsor ICMJE | Forest Laboratories | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Forest Laboratories | |||
Verification Date | September 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |