Ceftriaxone in the Management of Bipolar Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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||Phase|
|Bipolar Depression||Drug: ceftriaxone Drug: Saline solution||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2009|
|Actual 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.
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): 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|