Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with severe treatment-resistant MDD Currently depressed Currently under regular psychiatric care On an aggressive antidepressant regimen, stable for 4 weeks Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine IV<br>Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks | Drug: Ketamine<br>* Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weekly for total duration of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment resistant, suicidal ideation, major depressive disorder