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

First Received on November 29, 2007. Last Updated on October 14, 2009 History of Changes

Sponsor:	Yale University
Collaborator:	Stanley Medical Research Institute
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00566111

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:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Ceftriaxone Ceftriaxone Sodium

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:

Mineur YS, Picciotto MR, Sanacora G. Antidepressant-like effects of ceftriaxone in male C57BL/6J mice. Biol Psychiatry. 2007 Jan 15;61(2):250-2. Epub 2006 Jul 24.

Rothstein JD, Patel S, Regan MR, Haenggeli C, Huang YH, Bergles DE, Jin L, Dykes Hoberg M, Vidensky S, Chung DS, Toan SV, Bruijn LI, Su ZZ, Gupta P, Fisher PB. Beta-lactam antibiotics offer neuroprotection by increasing glutamate transporter expression. Nature. 2005 Jan 6;433(7021):73-7.

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 February 12, 2012