Ceftriaxone in the Management of Bipolar Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

October 14, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Hamilton Depression Rating Scale (HDRS) score from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00566111 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ceftriaxone in the Management of Bipolar Depression

Official Title ^ICMJE

Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bipolar Depression

Intervention ^ICMJE

Drug: ceftriaxone
Drug: Saline solution

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kathleen Maloney, BA

203-974-7496

kathleen.maloney@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00566111

Responsible Party

Gerard Sanacora, Yale University

Study ID Numbers ^ICMJE

06T-812, HIC#0704002567

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Stanley Medical Research Institute

Investigators ^ICMJE

Principal Investigator:	Zubin Bhagwagar, MD PhD	Yale University
Principal Investigator:	Gerard Sanacora, MD PhD	Yale University

Information Provided By

Yale University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP