DepressionPhase 2KetamineNCT02094898
Ketamine for Depression and Suicide Risk
A Phase 2 study testing Ketamine in people with Depression and Suicide, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Suicide
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2016
- Phase
- Phase 2
- 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
- Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
- Ability to provide informed consent
- Male/Female
- Age 18-65 yrs.
- Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment
- Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks
Show all 9Show fewer
- Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R) or score of ≥1on Item 9 of PHQ-9 (all at admission assessment)
- Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria
- Voluntary admission
Who cannot join
- Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
- Index episode of depression greater than 2 years
- Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
- Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
- Any active or unstable medical condition as judged by principal investigator
- Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months
Show all 15Show fewer
- Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, < 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.
- History of traumatic brain injury
- Developmental delay and intellectual disorder
- Encephalopathy (clinical diagnosis within prior 12 months of delirium)
- Cognitive disorder (mild and major)
- Previous participation in earlier Ketamine trial
- Pregnancy
- Prisoners
- Involuntarily hospitalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt
The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.
Read the detailed description
This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.
- Conditions
- Depression, Suicide
- Being tested
- Ketamine
- Keywords
- Depression, Unipolar, Bipolar, Suicidal
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
0.3 mg/kg/hr of ketamine infused for 100 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ketamine infusion | Experimental | This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS Total Score at Baseline and Last Acute Phase Observation
The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Measured: baseline, last acute phase observation (approximately 2 weeks)
Secondary outcomes (13)
MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation
The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Measured: baseline, last acute phase observation
MADRS Factor 2 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Measured: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Measured: baseline, last acute phase observation (approximately 2 weeks)
Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation
The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Measured: baseline, last acute phase observation (approximately 2 weeks)
CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation
The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Measured: baseline, last acute phase observation (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionAug 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William V. Bobo, M.D., Mayo Clinic
- Investigators
- William V Bobo, MD, Principal investigator, Consultant - Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094898
- Sponsor's protocol ID
- 13-005152
- Acronym
- Ketamine
- Status last verified
- Aug 2017
- First submitted
- 10 Mar 2014
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12.
PubMed 27656788
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt
- ClinicalTrials.gov ID
- NCT02094898
- Acronym / sponsor ID
- Ketamine / 13-005152
- Conditions
- Depression, Suicide
- Keywords
- Depression, Unipolar, Bipolar, Suicidal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 11 Aug 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 research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.
Detailed description
This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine infusion | Experimental | Drug: KetamineThis trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
- Ability to provide informed consent
- Male/Female
- Age 18-65 yrs.
- Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment
Key exclusion criteria (15 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
- Index episode of depression greater than 2 years
- Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
- Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
- Any active or unstable medical condition as judged by principal investigator
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 |
|---|---|---|
| KetamineAlso: Ketalar0.3 mg/kg/hr of ketamine infused for 100 minutes | Drug | Ketamine infusion |
Primary outcome
MADRS Total Score at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
13 secondary outcomes
MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation
MADRS Factor 2 Score at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation
Time frame: baseline, last acute phase observation (approximately 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27656788Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12.
- Individual participant dataSharing planned: Undecided
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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.
William V Bobo, MD principal investigator
Consultant - Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine in people with Depression and Suicide, run by Mayo Clinic 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 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 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?
Yes. Results are posted in the registry (first posted 11 Aug 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?
MADRS Total Score at Baseline and Last Acute Phase Observation (time frame: baseline, last acute phase observation (approximately 2 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 NCT02094898, which also lists 1 linked publication.
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 11 Aug 2017.