Bipolar Depression
Conditions
Keywords
Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders
Brief 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.
Interventions
DRUGceftriaxone
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
DRUGSaline solution
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Sponsors
Stanley Medical Research Institute
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. | 4 weeks | Number of patients with scores that decreased at four weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline. | 4 weeks | Number of patients with scores that decreased at four 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. | 4 weeks | The number of patients that had a decrease on MADRS at 4 weeks. |
| Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). | 4 weeks | The number of patients that had a decrease on CGI-BP at 4 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ceftriaxone ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. | 2 |
| Placebo Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks. | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Ceftriaxone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
Number of patients with scores that decreased at four weeks.
Time frame: 4 weeks
Population: only participants with complete data at 4 weeks were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftriaxone | Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. | 2 participants |
| Placebo | Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. | 1 participants |
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.
Time frame: 4 weeks
Population: only participants with complete data at 4 weeks were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftriaxone | Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline. | 2 participants |
| Placebo | Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline. | 0 participants |
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.
Time frame: 4 weeks
Population: only patients with complete data at 4 weeks were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftriaxone | Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). | 2 participants |
| Placebo | Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). | 1 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.
Time frame: 4 weeks
Population: These data were not collected.
Secondary
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.
Time frame: 4 weeks
Population: only participants with complete data at 4 weeks were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceftriaxone | Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. | 0 participants |
| Placebo | Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7. | 0 participants |