Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

Study Overview
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Brief Summary
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A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.

Official Title
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Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

Conditions
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Depressive Disorder,, Treatment-Resistant Depression

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years old Mayor Depressive Disorder Diagnosis based on DSM-IV TR. Classification of MDD as treatment-resistant. No brain structural abnormalities as evidenced by an MRI scan. Signed acceptance of Informed Consent. Exclusion Criteria: Other psychiatric diagnosis apart from MDD. Substance abuse or dependence (prior or during study). Pregnancy. Congestive heart disease. Personal history of psychosis. First-degree relative with history of psychosis. Glaucoma. Present neurological disease. High blood or pulmonary artery pressure. Declining the signing of the informed consent.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine treated<br> | Drug: Ketamine<br>* A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.<br>* Other names: Ketalar;|
| Placebo Comparator: Control, placebo treated<br> | Drug: Placebo<br>* Saline at 0.9% intravenous infusion will be administered over 40 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in baseline HDRS Score | The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained. | 20 minutes before and 40 minutes after ketamine infusion. | 
| Daily change in HDRS post-ketamine infusion. | On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation. | 1,2,3,4,5,6 and 7. Days after ketamine infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline blood pressure (BP). | Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion. | 20 minutes before ketamine infusion. | 
| Changes from baseline in blood pressure (BP) | BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting. | every 5 minutes in a 300 minutes period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Depression, Depressive Disorder