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Early indication of an unfavorable risk/benefit ratio.
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftriaxone | Drug | 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. | Number of patients with scores that decreased at four weeks. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubin Bhagwagar, MD PhD | Yale University | Principal Investigator |
| Gerard Sanacora, MD PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16860779 | Background | 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. | |
| 15635412 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftriaxone | ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. |
| FG001 | Placebo | Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftriaxone | ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. |
| BG001 | Placebo | Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. | Number of patients with scores that decreased at four weeks. | only participants with complete data at 4 weeks were analyzed | Posted | Number | participants | 4 weeks |
|
Up to 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftriaxone | ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerard Sanacora | Yale University Department of Psychiatry | (203) 974-7535 | gerard.sanacora@yale.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Saline solution | Drug | Saline solution will be administered IV via midline, 7 days a week for 4 weeks. |
|
| 4 weeks |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | These data were not collected. | Posted | 4 weeks |
|
|
| Secondary | Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. | only participants with complete data at 4 weeks were analyzed | Posted | Number | participants | 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. | only participants with complete data at 4 weeks were analyzed | Posted | Number | participants | 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. | only patients with complete data at 4 weeks were analyzed | Posted | Number | participants | 4 weeks |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks. | 0 | 3 | 2 | 3 |
| Difficulty Concentrating | General disorders | Systematic Assessment |
|
| Poor Coordination | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Tremors | Nervous system disorders | Systematic Assessment |
|
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| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |