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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Yale University School of Medicine
New Haven, Connecticut, United States
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
Number of patients with scores that decreased at four weeks.
Time frame: 4 weeks
Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.
Number of patients with scores that decreased at four weeks.
Time frame: 4 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.
The number of patients that had a decrease on MADRS at 4 weeks.
Time frame: 4 weeks
Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).
The number of patients that had a decrease on CGI-BP at 4 weeks.
Time frame: 4 weeks
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