Bipolar DepressionPhase 2NCT01768767
Trial of Ketamine and Lithium Therapy in Bipolar Depression
A Phase 2 study testing Ketamine and Ketamine/Lithium in people with Bipolar Depression, run by Yale University.
Trial summary
This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them. 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?
- Ketamine and Ketamine/Lithium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female between the ages of 18-65 years. Females will be included if they are not pregnant and agreed to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
- Able to provide written informed consent according to Yale HIC guidelines.
- Bipolar Disorder in Major Depressive Episode (296.5x or 296.89), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition 80
- Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher.
- Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher.
- Be able to understand and speak English.
Who cannot join
- Patients with a history of DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression.
- Patients with current hypomanic and/or manic symptoms meeting DSM-IV-TR criteria of mixed episode are excluded.
- DSM IV-TR Axis I disorders are excluded if they are considered primary disorders.
- Dementia or suspicion thereof, is also exclusionary.
- Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- Substance abuse or dependence during the 3 months prior to screening.
Show all 16Show fewer
- History of serious medical or neurological illness.
- Signs of major medical or neurological illness on examination or as a result of a 12 lead ECG screening or laboratory studies.
- Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
- Positive urine drug screen.
- Pregnant or lactating women or a positive urine pregnancy test; for women of childbearing potential.
- Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C) will be excluded as a means to (1) protect the subjects and research staff from the increased risks of blood borne pathogen transmission during placebo/ketamine infusions and (2) to minimize the factors which might influence the biochemical responses and affect the study outcome. This test will take place at the screening visit. Subjects will be invited back to the Yale Depression Research Program, either for their next study visit or for a HIV/Hep debriefing session. HIV results will be given in a face to face meeting no matter what the results are.
- Patients requiring excluded medications (see Table 3 for details).
- History indicating learning disability or mental retardation.
- Known sensitivity to ketamine or lithium.
- Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 50/min or higher than 100/min.
About this study
Official title: Novel Approach of Combined Lithium-Ketamine Therapy in Bipolar Depression: To Preserve Efficacy and Minimize Adverse Effects
This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them.
- Conditions
- Bipolar Depression
- Being tested
- Placebo, Ketamine, Ketamine/Lithium
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
KetamineDrug
Ketamine/LithiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketamine/Lithium | Experimental | Participant will receive ketamine/lithium Receives: Drug: Ketamine/Lithium |
| Ketamine | Active comparator | Participant will receive ketamine Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Participant will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 4 Hours to 2 weeks
Secondary outcomes (2)
Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)
Measured: 4 hours to 2 weeks
Clinical Global Impressions Scale (CGI)
Measured: 4 hours to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chadi Abdallah, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768767
- Sponsor's protocol ID
- 1209010758
- Other IDs
- T32DA022975
- Status last verified
- Mar 2020
- First submitted
- 9 Jan 2013
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach of Combined Lithium-Ketamine Therapy in Bipolar Depression: To Preserve Efficacy and Minimize Adverse Effects
- ClinicalTrials.gov ID
- NCT01768767
- Acronym / sponsor ID
- 1209010758
- Conditions
- Bipolar Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine/Lithium | Experimental | Drug: Ketamine/LithiumParticipant will receive ketamine/lithium |
| Ketamine | Active comparator | Drug: KetamineParticipant will receive ketamine |
| Placebo | Placebo comparator | Drug: PlaceboParticipant will receive placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female between the ages of 18-65 years. Females will be included if they are not pregnant and agreed to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
- Able to provide written informed consent according to Yale HIC guidelines.
- Bipolar Disorder in Major Depressive Episode (296.5x or 296.89), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition 80
- Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher.
- Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher.
Key exclusion criteria (16 listed)
- Patients with a history of DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression.
- Patients with current hypomanic and/or manic symptoms meeting DSM-IV-TR criteria of mixed episode are excluded.
- DSM IV-TR Axis I disorders are excluded if they are considered primary disorders.
- Dementia or suspicion thereof, is also exclusionary.
- Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| Ketamine | Drug | Ketamine |
| Ketamine/Lithium | Drug | Ketamine/Lithium |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 4 Hours to 2 weeks
2 secondary outcomes
Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)
Time frame: 4 hours to 2 weeks
Clinical Global Impressions Scale (CGI)
Time frame: 4 hours to 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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.
Chadi Abdallah, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Ketamine/Lithium in people with Bipolar Depression, run by Yale University.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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: 4 Hours to 2 weeks). 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 1 Mar 2023.