Ceftriaxone in the Management of Bipolar Depression
|ClinicalTrials.gov Identifier: NCT00566111|
Recruitment Status : Terminated (Early indication of an unfavorable risk/benefit ratio.)
First Posted : December 3, 2007
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment|
|Bipolar Depression||Drug: ceftriaxone Drug: Saline solution|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression|
|Study Start Date :||September 2007|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
|Active Comparator: A||
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
|Placebo Comparator: P||
Drug: Saline solution
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
- Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. [ Time Frame: 4 weeks ]Number of patients with scores that decreased at four weeks.
- Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline. [ Time Frame: 4 weeks ]Number of patients with scores that decreased at four weeks.
- Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. [ Time Frame: 4 weeks ]
- Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline. [ Time Frame: 4 weeks ]The number of patients that had a decrease on MADRS at 4 weeks.
- Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 4 weeks ]The number of patients that had a decrease on CGI-BP at 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566111
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Zubin Bhagwagar, MD PhD||Yale University|
|Principal Investigator:||Gerard Sanacora, MD PhD||Yale University|