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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00566111
Other study ID # 0704002567
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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