Intranasal Ketamine in Treatment-Resistant Depression

Study Overview
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Brief Summary
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The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Official Title
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Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Ketamine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, 21-65 years; Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study; Primary diagnosis of major depressive disorder as assessed by the SCID-P; Current depressive episode; History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode; Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2; Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document; Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact. Exclusion Criteria: Women who plan to become pregnant, are pregnant or are breast-feeding; Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease; Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG; Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome; Drug or alcohol abuse or dependence within the preceding 6 months; Lifetime abuse or dependence on ketamine or phencyclidine; Patients judged by study investigator to be at high risk for suicide. Previous participation in a ketamine study at Mount Sinai

Ages Eligible for Study
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Minimum Age: 21 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Subjects randomized to this arm will receive the active study medication, intranasal ketamine. | Drug: Ketamine<br>* A single dose of intranasal ketamine up to 50 mg<br>|
| Placebo Comparator: Placebo<br>Subjects randomized to this arm will receive intranasal saline. | Drug: placebo<br>* Single dose of saline intranasal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systematic Assessment for Treatment Emergent Effects (SAFTEE) | This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, depression, treatment resistance, intranasal, antidepressant, glutamate, NMDA receptor