Ketamine Frequency Treatment for Major Depressive Disorder

Treatment Resistant Depression Clinical Trial

Official title:

Ketamine Frequency Treatment for Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00646087
• Other study ID #: 04-07-04
• Status: Withdrawn
• Phase: Phase 4
• First received: March 25, 2008
• Last updated: June 3, 2011
• Start date: March 2008

Study information

• Verified date: June 2011
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	St. Mary's Duluth Clinic Health System	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

Beck AT, Beamesderfer A. Assessment of depression: the depression inventory. Mod Probl Pharmacopsychiatry. 1974;7(0):151-69. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62. — View Citation

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

Holtzheimer PE 3rd, Nemeroff CB. Advances in the treatment of depression. NeuroRx. 2006 Jan;3(1):42-56. Review. — View Citation

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. — View Citation

Leonard B. Clinical implications of mechaniszms of action of antidepresants. Advan Psychiatr Treat. 2000;6:178-186.

Nierenberg AA, Amsterdam JD. Treatment-resistant depression: definition and treatment approaches. J Clin Psychiatry. 1990 Jun;51 Suppl:39-47; discussion 48-50. Review. — View Citation

Overall J, Gorham D. The brief psychiatric rating scale. Psycol Rep. 1962;10:799-812.

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

Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9. Review. — View Citation

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.

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

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale.		20 weeks	No
Secondary	Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact.		20 weeks	No