Ketamine Frequency Treatment for Major Depressive Disorder
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 65%.
This randomized clinical trial will examine the frequency of treatment with ketamine in patients with treatment-resistant depression TRD 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.
|Treatment Resistant Depression||Drug: Ketamine Drug: Ketamine/Saline||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ketamine Frequency Treatment for Major Depressive Disorder|
- The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale. [ Time Frame: 20 weeks ]
- Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact. [ Time Frame: 20 weeks ]
|Study Start Date:||March 2008|
Experimental: Ketamine (6K)
6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days
0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
Active Comparator: Ketamine/Placebo (2K4P)
2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.
0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646087
|United States, Minnesota|
|St. Mary's Duluth Clinic Health System|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Micheal Messer, MD||Essentia Health|