Ketamine Infusion for Treatment-resistant Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT01582945|
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Ketamine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Ketamine IV
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582945
|United States, Massachusetts|
|Depression Clinical and Research Program - MGH|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Cristina Cusin, MD||MGH Department of Psychiatry|