A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
|ClinicalTrials.gov Identifier: NCT00644358|
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: vilazodone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||616 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder|
|Actual Study Start Date :||December 31, 2007|
|Primary Completion Date :||May 31, 2009|
|Study Completion Date :||May 31, 2009|
Vilazodone titrated up to 40 mg/day for 1 year.
titration to 40 milligrams (mg) every day (qd) for 1 year
Other Name: EMD 68843, SB-659746
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months) ]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).
- Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination ]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.
- Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination ]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.
- Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644358
Show 38 Study Locations
|Study Director:||Carol R Reed, MD||Forest Laboratories|