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| Sponsors and Collaborators: |
Yale University Stanley Medical Research Institute |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00566111 |
Purpose
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.
| Condition | Intervention |
|
Bipolar Depression |
Drug: ceftriaxone Drug: Saline solution |
| MedlinePlus related topics: | Bipolar Disorder Depression |
| ChemIDplus related topics: | Sodium chloride Ceftriaxone Ceftriaxone Sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Active Comparator |
Drug: ceftriaxone
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
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| P: Placebo Comparator |
Drug: Saline solution
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
|
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen Maloney, BA | 203-974-7496 | kathleen.maloney@yale.edu |
| Contact: Jason Chen, BA | 203-974-7559 | jason.chen.jc64@yale.edu |
| United States, Connecticut | |||||
| Yale University School of Medicine | Recruiting | ||||
| New Haven, Connecticut, United States, 06519 | |||||
| Principal Investigator: Zubin Bhagwagar, MD PhD | |||||
| Principal Investigator: Gerard Sanacora, MD PhD | |||||
| Yale University |
| Stanley Medical Research Institute |
| Principal Investigator: | Zubin Bhagwagar, MD PhD | Yale University |
More Information
| Responsible Party: | Yale University ( Zubin Bhagwagar ) |
| Study ID Numbers: | 06T-812, HIC#0704002567 |
| First Received: | November 29, 2007 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00566111 |
| Health Authority: | United States: Food and Drug Administration |
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