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Ceftriaxone in the Management of Bipolar Depression

This study has been terminated.
(Early indication of an unfavorable risk/benefit ratio.)
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University Identifier:
First received: November 29, 2007
Last updated: August 25, 2016
Last verified: August 2016
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of patients with scores that decreased at four weeks.

Secondary Outcome Measures:
  • 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 patients with scores that decreased at four weeks.

  • 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 ]
    The number of patients that had a decrease on MADRS at 4 weeks.

  • Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The number of patients that had a decrease on CGI-BP at 4 weeks.

Enrollment: 5
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: ceftriaxone
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
Other Names:
  • Rocephin
  • Ceftriaxone Sodium
Placebo Comparator: P Drug: Saline solution
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00566111

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Principal Investigator: Zubin Bhagwagar, MD PhD Yale University
Principal Investigator: Gerard Sanacora, MD PhD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00566111     History of Changes
Other Study ID Numbers: 06T-812  HIC#0704002567 
Study First Received: November 29, 2007
Results First Received: August 25, 2016
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Acute Antidepressant Effects
Glutamatergic System
Mood Disorders
Bipolar Disorder
Affective Disorders

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Anti-Bacterial Agents
Anti-Infective Agents processed this record on October 21, 2016