Bipolar DisorderPhase 4NCT00947791
Treatment Study of Bipolar Depression
A Phase 4 study testing ketamine and midazolam in people with Bipolar Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- ketamine and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 4
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 21-70 years;
- Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
- Current depressive episode ≥ 8 weeks duration;
- History of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode (see above for definition for adequate trials);
- Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
- Subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment (with the exception of divalproex ER as above);
- Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1 and #2;
Who cannot join
- Women who plan to become pregnant, are pregnant or are breast-feeding;
- Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
- Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
- Lifetime history of schizophrenia, schizoaffective disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
- Current presence of psychotic, mixed or manic symptoms;
- Lifetime history of antidepressant-induced switch to a manic episode;
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- History of rapid cycling bipolar subtype;
- Drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years;
- Lifetime exposure to ketamine or phencyclidine;
- Patients judged by study investigator to be at high risk for suicide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Intravenous Ketamine in Treatment-Resistant Bipolar Depression
The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.
Read the detailed description
Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Depression, Treatment-Resistant, ketamine, antidepressant, glutamate
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
a single IV infusion of ketamine, IV 0.5 mg/kg
midazolamDrug
a single IV infusion of midazolam, 0.045 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Ketamine/Midazolam | Experimental | Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. Receives: Drug: ketamine; Drug: midazolam |
| Midazolam/Ketamine | Experimental | Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. Receives: Drug: ketamine; Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 24 hrs post-infusion compared to baseline
Secondary outcomes (5)
Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Measured: 24 hrs post-infusion compared to baseline
Young Mania Rating Scale (YMRS)
Measured: 24 hrs post-infusion compared to baseline
Brief Psychiatric Rating Scale (BPRS)
Measured: 4 hrs post-infusion compared to baseline
Clinician-Administered Dissociative States Scale (CADSS)
Measured: 4 hrs post-infusion compared to baseline
Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Measured: 4 hrs post-infusion compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Change in available resources for study procedures
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.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Murrough, Icahn School of Medicine at Mount Sinai
- Investigators
- James W Murrough, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947791
- Sponsor's protocol ID
- GCO 08-1422
- Status last verified
- Apr 2017
- First submitted
- 27 Jul 2009
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ketamine in Treatment-Resistant Bipolar Depression
- ClinicalTrials.gov ID
- NCT00947791
- Acronym / sponsor ID
- GCO 08-1422
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Depression, Treatment-Resistant, ketamine, antidepressant, glutamate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in available resources for study procedures
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.
Detailed description
Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine/Midazolam | Experimental | Drug: ketamine, Drug: midazolamPatients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. |
| Midazolam/Ketamine | Experimental | Drug: ketamine, Drug: midazolamPatients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients, 21-70 years;
- Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
- Current depressive episode ≥ 8 weeks duration;
- History of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode (see above for definition for adequate trials);
- Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
Key exclusion criteria (10 listed)
- Women who plan to become pregnant, are pregnant or are breast-feeding;
- Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
- Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
- Lifetime history of schizophrenia, schizoaffective disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
- Current presence of psychotic, mixed or manic symptoms;
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 |
|---|---|---|
| ketaminea single IV infusion of ketamine, IV 0.5 mg/kg | Drug | Ketamine/Midazolam, Midazolam/Ketamine |
| midazolama single IV infusion of midazolam, 0.045 mg/kg | Drug | Ketamine/Midazolam, Midazolam/Ketamine |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 24 hrs post-infusion compared to baseline
5 secondary outcomes
Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Time frame: 24 hrs post-infusion compared to baseline
Young Mania Rating Scale (YMRS)
Time frame: 24 hrs post-infusion compared to baseline
Brief Psychiatric Rating Scale (BPRS)
Time frame: 4 hrs post-infusion compared to baseline
Clinician-Administered Dissociative States Scale (CADSS)
Time frame: 4 hrs post-infusion compared to baseline
Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Time frame: 4 hrs post-infusion compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James W Murrough, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketamine and midazolam in people with Bipolar Disorder, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 10 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 17 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). 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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 24 hrs post-infusion compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.