Ketamine Frequency Treatment for Major Depressive Disorder
Information source: St. Mary's Duluth Clinic Health System
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Treatment Resistant Depression
Intervention: Ketamine (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: St. Mary's Duluth Clinic Health System
Official(s) and/or principal investigator(s):
Micheal Messer, MD, Principal Investigator, Affiliation: St. Mary's Duluth Clinic Health System
Depression is a wide spread illness. Depression contributes most significantly to national
health care costs. While the number and types of treatments used for depression have expanded
over the years, even with an increased range of options, the response rate, defined as the
number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around
In this pilot study we will assess the feasibility of conducting a randomized clinical trial
that will examine the frequency of treatment with ketamine in patients with TDR without
psychosis. It will compare two modes of the ketamine treatment; every other day ketamine,
versus two active and four placebo treatments over the period of 12 days.
Official title: Ketamine Frequency Treatment for Major Depressive Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study
Primary outcome: The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale.
Secondary outcome: · Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact.
Minimum age: 30 Years.
Maximum age: 65 Years.
- Age 30 to 65
- Major depressive disorder without psychotic features confirmed by a structured
clinical diagnostic interview, SCID.
- Treatment resistant depression defined using the Antidepressant Treatment History Form
- HDRS 21 score > 18
- Female participants of childbearing potential must be using a medically accepted means
of contraception (birth control pills, spermicidal barrier)
- Ability to concur with medication standardization regiment (section as an outpatient
- Physically healthy (no chronic diseases; normal CBC, BMP, AST, ALT, and UA)
- Competent to give informed consent to all required tests and examinations and sign a
- Bipolar disorder
- Psychosis or any other psychotic disorder as defined by DSM-IV criteria
- Serious or imminent threat for suicide
- Pregnant or nursing female
- Presence of serious unstable medical illnesses including hepatic, renal,
gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic,
immunologic, or hematologic disease, or abnormal laboratory tests (CBC, BMP, AST, ALT,
- Uncontrolled hypertension
- History of CVA
- Treatment with St. Johns wort, tramadol, phentolamine, naloxone, or anticholinergic
- Alcohol or illicit drug abuse for 6 months (evidence from UDS)
- Currently involved in a clinical trial or used an experimental medication within the
last 30 days
- Hypersensitivity to ketamine products
Locations and Contacts
St. Mary's Duluth Clinic Health System, Duluth, Minnesota 55805, United States
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Starting date: March 2008
Ending date: August 2008
Last updated: March 27, 2008