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Sponsors and Collaborators: |
Yale University Stanley Medical Research Institute |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00566111 |
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 |
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Bipolar Depression |
Drug: ceftriaxone Drug: Saline solution |
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 |
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Zubin Bhagwagar, MD PhD | Yale University |
Responsible Party: | Yale University ( Zubin Bhagwagar ) |
Study ID Numbers: | 06T-812, HIC#0704002567 |
Study First Received: | November 29, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00566111 |
Health Authority: | United States: Food and Drug Administration |
Ceftriaxone Acute Antidepressant Effects Glutamatergic System Double-Blind |
Mood Disorders Bipolar Disorder Depression Affective Disorders |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders |
Psychotic Disorders Ceftriaxone Depressive Disorder Behavioral Symptoms |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |