Bipolar DepressionNCT00566111

Ceftriaxone in the Management of Bipolar Depression

A study testing ceftriaxone and Saline solution in people with Bipolar Depression, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Depression
What is being tested?: ceftriaxone and Saline solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Dec 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Yale University School of Medicine
New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression

Conditions: Bipolar Depression
Being tested: ceftriaxone, Saline solution
Keywords: Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders
Medical subject headings: Bipolar Disorder, Mood Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ceftriaxoneDrug
Also called Rocephin, Ceftriaxone Sodium
2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
Saline solutionDrug
Saline solution will be administered IV via midline, 7 days a week for 4 weeks.

Study groups in NCT00566111
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: ceftriaxone
P	Placebo comparator	Not described Receives: Drug: Saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
Number of patients with scores that decreased at four weeks.
Measured: 4 weeks

Secondary outcomes (4)

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.
Measured: 4 weeks
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.
Measured: 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.
Measured: 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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Dec 2009

First posted3 Dec 2007 (estimated)
Study startSep 2007
Primary completionDec 2009
Study completionDec 2009

Why it stopped: Early indication of an unfavorable risk/benefit ratio.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DepressionStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00566111
Sponsor's protocol ID: 0704002567
Status last verified: Aug 2016
First submitted: 29 Nov 2007
Last updated: 31 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 16860779
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.
PubMed 15635412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression
ClinicalTrials.gov ID: NCT00566111
Acronym / sponsor ID: 0704002567
Conditions: Bipolar Depression
Keywords: Ceftriaxone, Acute Antidepressant Effects, Glutamatergic System, Double-Blind, Mood Disorders, Bipolar Disorder, Depression, Affective Disorders
Study type: Interventional
Recruitment status: TerminatedReason stopped: Early indication of an unfavorable risk/benefit ratio.
Enrolment: 5 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Sep 2007
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 3 Dec 2007 (estimated)
Results: Posted 19 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: ceftriaxone
P	Placebo comparator	Drug: Saline solution

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ceftriaxoneAlso: Rocephin, Ceftriaxone Sodium2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Drug	A
Saline solutionSaline solution will be administered IV via midline, 7 days a week for 4 weeks.	Drug	P

Primary outcome

Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
Time frame: 4 weeks
Number of patients with scores that decreased at four weeks.

4 secondary outcomes

Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.
Time frame: 4 weeks
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.
Time frame: 4 weeks
Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.
Time frame: 4 weeks
Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).
Time frame: 4 weeks

Results and safety

Results posted to the registry on 19 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ceftriaxone	2	2
Placebo	3	1

Primary outcome: Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.

Time frame: 4 weeks. Number. Unit: participants

Measure	Ceftriaxone n = 2	Placebo n = 1
Value	2	1

Population analysed: only participants with complete data at 4 weeks were analyzed

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ceftriaxone	0 of 2 (0%)	2 of 2 (100%)	Not reported
Placebo	0 of 3 (0%)	2 of 3 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16860779Mineur 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.
Background: PubMed 15635412Rothstein 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.

Related trials for Bipolar Depression

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zubin Bhagwagar, MD PhD principal investigator

Yale University

Gerard Sanacora, MD PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ceftriaxone and Saline solution in people with Bipolar Depression, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566111, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.