Ceftriaxone in the Management of Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00566111
• Other study ID #: 0704002567
• Status: Terminated
• Phase: N/A
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• ceftriaxone
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
• Saline solution
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & 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. Epub 2006 Jul 24. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.	Number of patients with scores that decreased at four weeks.	4 weeks
Secondary	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.	4 weeks
Secondary	Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.		4 weeks
Secondary	Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.	The number of patients that had a decrease on MADRS at 4 weeks.	4 weeks
Secondary	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.	4 weeks