Official Title: “Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2010

Intervention(s) in this Clinical Trial

• Drug: ceftriaxone
  • 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
• Drug: Saline solution
  • Saline solution will be administered IV via midline, 7 days a week for 4 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Placebo Comparator: P

Primary Measures

• Change in Hamilton Depression Rating Scale (HDRS) score from baseline.
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Change in score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) from baseline.
  • Time Frame: 4 weeks
    Safety Issue?: No
• Number of subjects who achieve remission as defined by a HDRS score < 7.
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in Montgomery Asberg Depression Rating Scale (MADRS)score from baseline.
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• DSM-IV diagnosis of bipolar disorder
• Presence of a current major depressive episode on the SCID
• Score of 17 or greater on the HDRS
• Failure to respond to two previous medication trials
• Capable of giving voluntary written consent

Exclusion Criteria:

• Hypersensitivity to penicillin or cephalosporin, resulting in anaphylaxis
• Significant current substance dependence/abuse within 3 months preceding the trial
• Significant history of intravenous drug abuse
• Active suicidal ideation
• Pregnant/lactating mothers
• Significant medical history
• Patients on anticoagulation treatment
• Patients who test positive for HIV or Hep B or C

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Zubin Bhagwagar, MD PhD Principal Investigator Yale University  

Overall Contact: Kathleen Maloney, BA 203-974-7496 kathleen.maloney@yale.edu

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00566111

Study ID Number: 06T-812

ClinicalTrials.gov Identifier: NCT00566111

Health Authority: United States: Food and Drug Administration