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| Descriptive Information Fields | |||||||||
| Brief Title † | Ceftriaxone in the Management of Bipolar Depression | ||||||||
| Official Title † | Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression | ||||||||
| Brief Summary | We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Change in Hamilton Depression Rating Scale (HDRS) score from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Change in score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Number of subjects who achieve remission as defined by a HDRS score < 7. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Change in Montgomery Asberg Depression Rating Scale (MADRS)score from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Change in ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Bipolar Depression | ||||||||
| Intervention † | Drug: ceftriaxone Drug: Saline solution |
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| MEDLINE PMIDs | 16860779, 15635412 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 30 | ||||||||
| Start Date † | September 2007 | ||||||||
| Completion Date | October 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00566111 | ||||||||
| Organization ID | 06T-812 | ||||||||
| Secondary IDs †† | HIC#0704002567 | ||||||||
| Study Sponsor † | Yale University | ||||||||
| Collaborators †† | Stanley Medical Research Institute | ||||||||
| Investigators † |
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| Information Provided By | Yale University | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | November 29, 2007 | ||||||||
| Last Updated Date | July 31, 2008 | ||||||||
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