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Ceftriaxone in the Management of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00566111
Recruitment Status : Terminated (Early indication of an unfavorable risk/benefit ratio.)
First Posted : December 3, 2007
Results First Posted : October 19, 2016
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Depression Drug: ceftriaxone Drug: Saline solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression
Study Start Date : September 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. [ Time Frame: 4 weeks ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566111


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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00566111    
Other Study ID Numbers: 0704002567
First Posted: December 3, 2007    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: March 31, 2020
Last Verified: August 2016
Keywords provided by Yale University:
Ceftriaxone
Acute Antidepressant Effects
Glutamatergic System
Double-Blind
 Mood Disorders
Bipolar Disorder
Depression
Affective Disorders
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Bipolar and Related Disorders
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents