Ceftriaxone in the Management of Bipolar Depression
Status
Terminated
Conditions
Bipolar Depression
Treatments
Drug: ceftriaxone
Drug: Saline solution
Details and patient eligibility
About
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.
Enrollment
5 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
5 participants in 2 patient groups, including a placebo group
A
Active Comparator group
Treatment:
Drug: ceftriaxone
P
Placebo Comparator group
Treatment:
Drug: Saline solution
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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