NCT00566111

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

October 19, 2016

Completed
Last Updated

March 31, 2020

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

November 29, 2007

Results QC Date

August 25, 2016

Last Update Submit

March 27, 2020

Conditions

Bipolar Depression

Keywords

CeftriaxoneAcute Antidepressant EffectsGlutamatergic SystemDouble-BlindMood DisordersBipolar DisorderDepressionAffective Disorders

Outcome Measures

Primary Outcomes (1)

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

    Number of patients with scores that decreased at four weeks.

    4 weeks

Secondary Outcomes (4)

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

    4 weeks

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

    4 weeks

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

    4 weeks

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

    4 weeks

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: ceftriaxone

P

PLACEBO COMPARATOR
Drug: Saline solution

Interventions

ceftriaxoneDRUG

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

Also known as: Rocephin, Ceftriaxone Sodium
A
Saline solutionDRUG

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

P

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

  • 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.

    PMID: 16860779BACKGROUND

  • 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.

    PMID: 15635412BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderMood DisordersDepression

Interventions

CeftriaxoneSaline Solution

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Gerard Sanacora
Organization
Yale University Department of Psychiatry
gerard.sanacora@yale.edu
(203) 974-7535

Study Officials

  • Zubin Bhagwagar, MD PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Gerard Sanacora, MD PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 31, 2020

Results First Posted

October 19, 2016

Record last verified: 2016-08

Locations

US(1)