Ketamine Frequency Treatment for Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00646087|
Recruitment Status : Withdrawn (Pilot study determined that this study would not be feasible.)
First Posted : March 28, 2008
Last Update Posted : June 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Drug: Ketamine Drug: Ketamine/Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ketamine Frequency Treatment for Major Depressive Disorder|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646087
|United States, Minnesota|
|St. Mary's Duluth Clinic Health System|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Micheal Messer, MD||Essentia Health|