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Ceftriaxone in the Management of Bipolar Depression

Primary Purpose

Bipolar Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ceftriaxone

Saline solution

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.

Number of patients with scores that decreased at four weeks.

Secondary Outcome Measures

Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.

Number of patients with scores that decreased at four weeks.

Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.

Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.

The number of patients that had a decrease on MADRS at 4 weeks.

Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).

The number of patients that had a decrease on CGI-BP at 4 weeks.

Full Information

NCT ID

NCT00566111

First Posted

November 29, 2007

Last Updated

March 27, 2020

Sponsor

Yale University

Collaborators

Stanley Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00566111

Brief Title

Ceftriaxone in the Management of Bipolar Depression

Official Title

Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

Early indication of an unfavorable risk/benefit ratio.

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

Keywords

Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ceftriaxone

Other Intervention Name(s)

Rocephin, Ceftriaxone Sodium

Intervention Description

2g per day which will be administered IV via midline, 7 days a week for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Saline solution

Intervention Description

Saline solution will be administered IV via midline, 7 days a week for 4 weeks.

Primary Outcome Measure Information:

Title

Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.

Description

Number of patients with scores that decreased at four weeks.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.

Description

Number of patients with scores that decreased at four weeks.

Time Frame

4 weeks

Title

Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.

Time Frame

4 weeks

Title

Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.

Description

The number of patients that had a decrease on MADRS at 4 weeks.

Time Frame

4 weeks

Title

Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).

Description

The number of patients that had a decrease on CGI-BP at 4 weeks.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zubin Bhagwagar, MD PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gerard Sanacora, MD PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16860779

Citation

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. doi: 10.1016/j.biopsych.2006.04.037. Epub 2006 Jul 24.

Results Reference

background

PubMed Identifier

15635412

Citation

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. doi: 10.1038/nature03180.

Results Reference

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Ceftriaxone in the Management of Bipolar Depression

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