Clinical Trial: 12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
Brief Summary: The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.
Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc
Current Primary Outcome: The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. [ Time Frame: 17 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) [ Time Frame: 12 weeks ]
- The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) [ Time Frame: 12 weeks ]
Original Secondary Outcome:
- Change from baseline on mean score for the QIDS SR16. [ Time Frame: 17 weeks ]
- Change from baseline on mean score of Beck Anxiety Inventory. [ Time Frame: 17 weeks ]
- The occurrence of suicidal behavior or ideation as a change from baseline on the C SSRS. [ Time Frame: 17 weeks ]
Information By: Sprout Pharmaceuticals, Inc
Dates:
Date Received: December 28, 2009
Date Started: January 2010
Date Completion:
Last Updated: July 14, 2016
Last Verified: July 2016
