Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
(VLZ-MD-22 Trial)
Recruiting in Palo Alto (17 mi)
+59 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Forest Laboratories
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
Research Team
EM
Emily McCusker, PhD
Principal Investigator
Forest Research Institute, an affiliate of Allergan plc.
Eligibility Criteria
Inclusion Criteria
Male or Female outpatients between 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
See 1 more
Treatment Details
Interventions
- Fluoxetine (Selective Serotonin Reuptake Inhibitor (SSRI))
- Placebo (Other)
- Vilazodone (Serotonin Receptor Agonist and Reuptake Inhibitor)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VilazodoneExperimental Treatment1 Intervention
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Group II: FluoxetineActive Control1 Intervention
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Group III: PlaceboPlacebo Group1 Intervention
Dose-matched placebo tablets or capsules, oral administration, once per day.
Fluoxetine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prozac for:
- Depression
- Anxiety
- Obsessive-compulsive disorder
- Bulimia nervosa
- Panic disorder
🇪🇺 Approved in European Union as Prozac for:
- Major depressive episodes
- Obsessive-compulsive disorder
- Bulimia nervosa
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institute for Advanced Medical ResearchAlpharetta, GA
Baber Research GroupNaperville, IL
Northwest Behavioral Research CenterMarietta, GA
BioScience Research LLCMount Kisco, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Forest Laboratories
Lead Sponsor
Trials
338
Patients Recruited
89,200+
Founded
1956
Headquarters
New York City, USA
Known For
Depression Medications
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