Vortioxetine Versus Placebo in Major Depressive Disorder Comorbid With Social Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT02294305|
Recruitment Status : Unknown
Verified August 2016 by The Medical Research Network.
Recruitment status was: Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : August 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder Major Depressive Disorder||Drug: Vortioxetine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Vortioxetine 10 to 20 mg PO QD for 12 weeks.
Other Name: Brintellix
Placebo Comparator: Placebo
Placebo PO QD for 12 weeks.
- Clinical Global Impression of Improvement (CGI-I) Responder Rate [ Time Frame: 12 weeks ]CGI-I score of 2 (much improved) or 1 (very much improved) based on overall subject state, combining improvement in MDD and SAD features, at Visit 9/Early Termination
- Change in total Montgomery Asberg Depression Rating Scale (MADRS) score [ Time Frame: Baseline and 12 Weeks ]
- Change in total Liebowitz Social Anxiety Scale (LSAS) score [ Time Frame: Baseline and 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294305
|United States, New York|
|The Medical Research Network, LLC|
|New York, New York, United States, 10128|
|Principal Investigator:||Michael R Liebowitz, M.D.||The Medical Research Network, LLC|