Ceftriaxone in the Management of Bipolar Depression

Not Applicable

Terminated

• Conditions: Bipolar Depression
• Interventions: Drug: Saline solution; Drug: ceftriaxone

• Registration Number: NCT00566111
• Lead Sponsor: Yale University

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

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-08
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-08-25
• Results First Posted: 2016-10-19
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Saline solution	-
A	ceftriaxone	-

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.	4 weeks	Number of patients with scores that decreased at four weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.	4 weeks	The number of patients that had a decrease on MADRS at 4 weeks.
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.	4 weeks
Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.	4 weeks	Number of patients with scores that decreased at four weeks.
Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).	4 weeks	The number of patients that had a decrease on CGI-BP at 4 weeks.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States