Bipolar Depression Clinical Trial
Official title:
Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression
Verified date | August 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Stanley Medical Research Institute |
United States,
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
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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