Intranasal Ketamine in Treatment-Resistant Depression
This study has been completed.
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai
First received: February 23, 2011
Last updated: December 16, 2016
Last verified: December 2016
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).
Major Depressive Disorder
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
Primary Outcome Measures:
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
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.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
Subjects randomized to this arm will receive the active study medication, intranasal ketamine.
A single dose of intranasal ketamine up to 50 mg
Placebo Comparator: Placebo
Subjects randomized to this arm will receive intranasal saline.
Single dose of saline intranasal
|Ages Eligible for Study:
||21 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01304147
|Icahn School of Medicine at Mount Sinai
|New York City, New York, United States, 10029 |
||James W Murrough, MD
||Icahn School of Medicine at Mount Sinai
||James Murrough, Principal Investigator, Icahn School of Medicine at Mount Sinai
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 23, 2011
|Results First Received:
||April 18, 2016
||December 16, 2016
Keywords provided by Icahn School of Medicine at Mount Sinai:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 20, 2017
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action