Ceftriaxone in the Management of Bipolar Depression

Study Overview
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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.

Official Title
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Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: ceftriaxone
* Drug: Saline solution


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: ceftriaxone<br>* 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.<br>* Other names: Ceftriaxone Sodium;|
| Placebo Comparator: P<br> | Drug: Saline solution<br>* Saline solution will be administered IV via midline, 7 days a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders