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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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 ]
    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 ]
  • Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline. [ Time Frame: 4 weeks ]
    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 ]
    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)
Sexes Eligible for Study:   All
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
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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
Study First Received: November 29, 2007
Results First Received: August 25, 2016
Last Updated: August 25, 2016

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
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