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.
Intranasal Ketamine in Treatment-Resistant Depression
Brief Summary
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).
Intervention / Treatment
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Ketamine (DRUG)A single dose of intranasal ketamine up to 50 mg
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Placebo (DRUG)Single dose of saline intranasal
Condition or Disease
- Major Depressive Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 21 Years to 65 Years |
| Enrollment: | 20 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Oct 01, 2011 | |
|---|---|---|
| Primary Completion: | Oct 01, 2014 | ACTUAL |
| Completion Date: | Oct 01, 2014 | ACTUAL |
| Study First Posted: | Feb 25, 2011 | ESTIMATED |
| Results First Posted: | Feb 08, 2017 | ESTIMATED |
| Last Updated: | Dec 16, 2016 |
Sponsors / Collaborators
Lead Sponsor:
James Murrough
Responsible Party:
James Murrough
Location
Participant Groups
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Subjects randomized to this arm will receive the active study medication, intranasal ketamine.
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Subjects randomized to this arm will receive intranasal saline.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 21 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Male or female patients, 21-65 years;
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
4. Current depressive episode;
5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
7. 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;
8. 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:
1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Drug or alcohol abuse or dependence within the preceding 6 months;
6. Lifetime abuse or dependence on ketamine or phencyclidine;
7. Patients judged by study investigator to be at high risk for suicide.
8. Previous participation in a ketamine study at Mount Sinai
1. Male or female patients, 21-65 years;
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
4. Current depressive episode;
5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
7. 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;
8. 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:
1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Drug or alcohol abuse or dependence within the preceding 6 months;
6. Lifetime abuse or dependence on ketamine or phencyclidine;
7. Patients judged by study investigator to be at high risk for suicide.
8. Previous participation in a ketamine study at Mount Sinai
Primary Outcomes
Secondary Outcomes
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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.
More Details
| NCT Number: | NCT01304147 |
|---|---|
| Other IDs: | GCO 11-0492 |
| Study URL: | https://clinicaltrials.gov/study/NCT01304147 |
Last updated: Sep 29, 2023