Ceftriaxone in the Management of Bipolar Depression

March 27, 2020 updated by: Yale University

Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
Time Frame: 4 weeks
Number of patients with scores that decreased at four weeks.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.
Time Frame: 4 weeks
4 weeks
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 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Zubin Bhagwagar, MD PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (ESTIMATE)

December 3, 2007

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0704002567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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