Major Depressive Disorder Clinical Trial
Official title:
Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
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).
Status | Completed |
Enrollment | 48 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
James Murrough |
United States,
Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | 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 | No |
Secondary | 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 | Yes |
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