Major Depressive DisorderNCT01582945
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
A study testing Ketamine in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- 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
- Outpatients with severe treatment-resistant MDD
- Currently depressed
- Currently under regular psychiatric care
- On an aggressive antidepressant regimen, stable for 4 weeks
Who cannot join
- No history of other major psychiatric illnesses, including bipolar disorder
- No history of psychosis
- No history of drug abuse
- No major medical illness or unstable medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program - MGH
Boston, Massachusetts, 02114
About this study
Official title: N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).
This is an open-label study (pilot).
Read the detailed description
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.
Total duration of the study is 5 months.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine
- Keywords
- Treatment resistant, suicidal ideation, major depressive disorder
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
| Study group | Role | What they receive |
|---|---|---|
| Ketamine IV | Experimental | Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
Measured: Weekly for total duration of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionDec 2014
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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Cusin, MD, Massachusetts General Hospital
- Investigators
- Cristina Cusin, MD, Principal investigator, MGH Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582945
- Sponsor's protocol ID
- 2010-P-002800
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2012
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ionescu DF, Swee MB, Pavone KJ, Taylor N, Akeju O, Baer L, Nyer M, Cassano P, Mischoulon D, Alpert JE, Brown EN, Nock MK, Fava M, Cusin C. Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.
PubMed 27232360Cusin C, Ionescu DF, Pavone KJ, Akeju O, Cassano P, Taylor N, Eikermann M, Durham K, Swee MB, Chang T, Dording C, Soskin D, Kelley J, Mischoulon D, Brown EN, Fava M. Ketamine augmentation for outpatients with treatment-resistant depression: Preliminary evidence for two-step intravenous dose escalation. Aust N Z J Psychiatry. 2017 Jan;51(1):55-64. doi: 10.1177/0004867416631828.
PubMed 26893373
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT01582945
- Acronym / sponsor ID
- 2010-P-002800
- Conditions
- Major Depressive Disorder
- Keywords
- Treatment resistant, suicidal ideation, major depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).
This is an open-label study (pilot).
Detailed description
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.
Total duration of the study is 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine IV | Experimental | Drug: KetaminePatients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients with severe treatment-resistant MDD
- Currently depressed
- Currently under regular psychiatric care
- On an aggressive antidepressant regimen, stable for 4 weeks
Key exclusion criteria (4 listed)
- No history of other major psychiatric illnesses, including bipolar disorder
- No history of psychosis
- No history of drug abuse
- No major medical illness or unstable medical conditions
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 |
|---|---|---|
| KetamineKetamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen | Drug | Ketamine IV |
Primary outcome
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
Time frame: Weekly for total duration of 4 months
Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27232360Ionescu DF, Swee MB, Pavone KJ, Taylor N, Akeju O, Baer L, Nyer M, Cassano P, Mischoulon D, Alpert JE, Brown EN, Nock MK, Fava M, Cusin C. Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.
- Results publication: PubMed 26893373Cusin C, Ionescu DF, Pavone KJ, Akeju O, Cassano P, Taylor N, Eikermann M, Durham K, Swee MB, Chang T, Dording C, Soskin D, Kelley J, Mischoulon D, Brown EN, Fava M. Ketamine augmentation for outpatients with treatment-resistant depression: Preliminary evidence for two-step intravenous dose escalation. Aust N Z J Psychiatry. 2017 Jan;51(1):55-64. doi: 10.1177/0004867416631828.
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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.
Cristina Cusin, MD principal investigator
MGH Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Major Depressive Disorder, run by Massachusetts General Hospital 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 4 inclusion and 4 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 20 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 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?
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) (time frame: Weekly for total duration of 4 months). 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 NCT01582945, 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 20 Apr 2017.