Ketamine Frequency Treatment for Major Depressive Disorder - Full Text View

Purpose

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	Intervention	Phase
Treatment Resistant Depression	Drug: Ketamine Drug: Ketamine/Saline	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ketamine Frequency Treatment for Major Depressive Disorder

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Essentia Health:

Primary Outcome Measures:

The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	March 2008

Arms	Assigned Interventions
Experimental: Ketamine (6K) 6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days	Drug: Ketamine 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.	Drug: Ketamine/Saline 0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11

Eligibility


Ages Eligible for Study:	30 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646087

Locations


United States, Minnesota
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

Essentia Health

Investigators


Principal Investigator:	Micheal Messer, MD	Essentia Health

More Information

Publications:

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Sackeim HA. The definition and meaning of treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:10-17. Burrows GD, Norman TR, Judd FK. Definition and differential diagnosis of treatment-resistant depression. Int Clin Psychopharmacol. Jun 1994;9 Suppl 2:5-10.

Burrows GD, Norman TR, Judd FK. Definition and differential diagnosis of treatment-resistant depression. Int Clin Psychopharmacol. 1994 Jun;9 Suppl 2:5-10. Review.

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.

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.

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.

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.

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.

Hirota K, Lambert DG. Ketamine: its mechanism(s) of action and unusual clinical uses. Br J Anaesth. 1996 Oct;77(4):441-4.

Paul IA, Skolnick P. Glutamate and depression: clinical and preclinical studies. Ann N Y Acad Sci. 2003 Nov;1003:250-72. Review.

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. Review.

Stewart CE. Ketamine as a street drug. Emerg Med Serv. 2001 Nov;30(11):30, 32, 34 passim. Review.

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.

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Responsible Party:	Micheal Messer MD, St. Mary's Duluth Clinic Health System
ClinicalTrials.gov Identifier:	NCT00646087 History of Changes
Other Study ID Numbers:	04-07-04
Study First Received:	March 25, 2008
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Depressive Disorder Depression Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mood Disorders Mental Disorders Behavioral Symptoms Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016