Intranasal Ketamine in Treatment-Resistant Depression
Completed · Not applicable · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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).
Key facts
- Study ID
- NCT01304147
- Run by
- James Murrough
- People needed
- 20
- Starts
- 2011-10-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2017-02-08
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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