Ketamine Frequency Treatment for Major Depressive Disorder
NCT ID: NCT00646087
Last Updated: 2011-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression
NCT02360280
Ketamine in Adolescents With Treatment-Resistant Depression
NCT02078817
A Study of Ketamine in Patients With Treatment-resistant Depression
NCT01627782
Ketamine in the Treatment of Depression
NCT01558063
Study of Depression-Ketamine-Brain Function
NCT01135758
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketamine (6K)
6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days
Ketamine
0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
Ketamine/Placebo (2K4P)
2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.
Ketamine/Saline
0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketamine
0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
Ketamine/Saline
0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Essentia Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
St. Mary's Duluth Clinic Health System
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Micheal Messer, MD
Role: PRINCIPAL_INVESTIGATOR
Essentia Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9.
Holtzheimer PE 3rd, Nemeroff CB. Advances in the treatment of depression. NeuroRx. 2006 Jan;3(1):42-56. doi: 10.1016/j.nurx.2005.12.007.
Nierenberg AA, Amsterdam JD. Treatment-resistant depression: definition and treatment approaches. J Clin Psychiatry. 1990 Jun;51 Suppl:39-47; discussion 48-50.
Burrows GD, Norman TR, Judd FK. Definition and differential diagnosis of treatment-resistant depression. Int Clin Psychopharmacol. 1994 Jun;9 Suppl 2:5-10. doi: 10.1097/00004850-199406002-00002.
Crown WH, Finkelstein S, Berndt ER, Ling D, Poret AW, Rush AJ, Russell JM. The impact of treatment-resistant depression on health care utilization and costs. J Clin Psychiatry. 2002 Nov;63(11):963-71. doi: 10.4088/jcp.v63n1102.
Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
Correll GE, Futter GE. Two case studies of patients with major depressive disorder given low-dose (subanesthetic) ketamine infusions. Pain Med. 2006 Jan-Feb;7(1):92-5. doi: 10.1111/j.1526-4637.2006.00101.x. No abstract available.
Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.
Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
Hirota K, Lambert DG. Ketamine: its mechanism(s) of action and unusual clinical uses. Br J Anaesth. 1996 Oct;77(4):441-4. doi: 10.1093/bja/77.4.441. No abstract available.
Paul IA, Skolnick P. Glutamate and depression: clinical and preclinical studies. Ann N Y Acad Sci. 2003 Nov;1003:250-72. doi: 10.1196/annals.1300.016.
Annetta MG, Iemma D, Garisto C, Tafani C, Proietti R. Ketamine: new indications for an old drug. Curr Drug Targets. 2005 Nov;6(7):789-94. doi: 10.2174/138945005774574533.
Stewart CE. Ketamine as a street drug. Emerg Med Serv. 2001 Nov;30(11):30, 32, 34 passim.
Correll GE, Maleki J, Gracely EJ, Muir JJ, Harbut RE. Subanesthetic ketamine infusion therapy: a retrospective analysis of a novel therapeutic approach to complex regional pain syndrome. Pain Med. 2004 Sep;5(3):263-75. doi: 10.1111/j.1526-4637.2004.04043.x.
Leonard B. Clinical implications of mechaniszms of action of antidepresants. Advan Psychiatr Treat. 2000;6:178-186.
Beck AT, Beamesderfer A. Assessment of depression: the depression inventory. Mod Probl Pharmacopsychiatry. 1974;7(0):151-69. doi: 10.1159/000395074. No abstract available.
Beck AT, Steer RA, Garbin MG. Psycometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clin Psychol Rev. 1988;8:77-100.
Overall J, Gorham D. The brief psychiatric rating scale. Psycol Rep. 1962;10:799-812.
Bremner JD, Krystal JH, Putnam FW, Southwick SM, Marmar C, Charney DS, Mazure CM. Measurement of dissociative states with the Clinician-Administered Dissociative States Scale (CADSS). J Trauma Stress. 1998 Jan;11(1):125-36. doi: 10.1023/A:1024465317902.
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
First MB, Spitzer RL, Miriam G, Williams JBW. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition. (SCID-I/P). New York: Biometrics Research, New York State Psychiatric Institute; 2002
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04-07-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.