Status:
WITHDRAWN
Ketamine Frequency Treatment for Major Depressive Disorder
Lead Sponsor:
Essentia Health
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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 (ATHF)
- 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 consent document
Exclusion
- 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, and UA)
- Uncontrolled hypertension
- History of CVA
- Treatment with St. Johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00646087
Start Date
March 1 2008
Last Update
June 6 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805