Ketamine Frequency Treatment for Major Depressive Disorder

Study Overview
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Brief Summary
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Depression is a wide spread illness. Depression contributes most significantly to national health care costs. While the number and types of treatments used for depression have expanded over the years, even with an increased range of options, the response rate, defined as the number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around 65%. This randomized clinical trial will examine the frequency of treatment with ketamine in patients with treatment-resistant depression TRD without psychosis. It will compare two modes of the ketamine treatment; every other day ketamine, versus two active and four placebo treatments over the period of 12 days.

Official Title
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Ketamine Frequency Treatment for Major Depressive Disorder

Conditions
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Treatment Resistant Depression

Intervention / Treatment
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* Drug: Ketamine
* Drug: Ketamine/Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 65 Major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, SCID. Treatment resistant depression defined using the Antidepressant Treatment History Form (ATHF) HDRS 21 score > 18 Female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier) Ability to concur with medication standardization regiment (section as an outpatient Physically healthy (no chronic diseases; normal CBC, BMP, AST, ALT, and UA) Competent to give informed consent to all required tests and examinations and sign a consent document Exclusion Criteria: Bipolar disorder Psychosis or any other psychotic disorder as defined by DSM-IV criteria Serious or imminent threat for suicide Pregnant or nursing female Presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (CBC, BMP, AST, ALT, and UA) Uncontrolled hypertension History of CVA Treatment with St. Johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications Alcohol or illicit drug abuse for 6 months (evidence from UDS) Currently involved in a clinical trial or used an experimental medication within the last 30 days Hypersensitivity to ketamine products

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine (6K)<br>6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days | Drug: Ketamine<br>* 0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)<br>|
| Active Comparator: Ketamine/Placebo (2K4P)<br>2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days. | Drug: Ketamine/Saline<br>* 0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale. |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact. |  | 20 weeks |