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Ceftriaxone in the Management of Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00566111
First received: November 29, 2007
Last updated: October 14, 2009
Last verified: October 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

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 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 ]
  • Change in ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566111

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

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

Publications:

Responsible Party: Gerard Sanacora, Yale University
ClinicalTrials.gov Identifier: NCT00566111     History of Changes
Other Study ID Numbers: 06T-812, HIC#0704002567
Study First Received: November 29, 2007
Last Updated: October 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Ceftriaxone
Acute Antidepressant Effects
Glutamatergic System
Double-Blind
 Mood Disorders
Bipolar Disorder
Depression
Affective Disorders

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
 Behavioral Symptoms
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013