Ceftriaxone in the Management of Bipolar Depression

NCT ID: NCT00566111

Last Updated: 2020-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

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

P

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

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

Interventions

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ceftriaxone

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

Intervention Type DRUG

Saline solution

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

Intervention Type DRUG

Other Intervention Names

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Rocephin Ceftriaxone Sodium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zubin Bhagwagar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Gerard Sanacora, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16860779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15635412 (View on PubMed)

Other Identifiers

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0704002567

Identifier Type: -

Identifier Source: org_study_id

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