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Ketamine Frequency Treatment for Major Depressive Disorder
This study has been withdrawn prior to enrollment.
( Pilot study determined that this study would not be feasible. )

First Received on March 25, 2008.   Last Updated on June 3, 2011   History of Changes
Sponsor: Essentia Health
Information provided by: Essentia Health
ClinicalTrials.gov Identifier: NCT00646087
  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 IV

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:

MedlinePlus related topics: Depression
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
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
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:
Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9. Review.
Holtzheimer PE, 3rd, Nemeroff CB. Advances in the treatment of depression. NeuroRx. Jan 2006;3(1):42-56
Fava M. Diagnosis and definition of treatment-resistant depression. Biol Psychiatry. Apr 15 2003;53(8):649-659. Nierenberg AA, Amsterdam JD. Treatment-resistant depression: definition and treatment approaches. J Clin Psychiatry. Jun 1990;51 Suppl:39-47; discussion 48-50.
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. 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.
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. No abstract available.
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.
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):151-169.
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.
Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. Feb 1960;23:56-62.

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

ClinicalTrials.gov processed this record on February 12, 2012



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