NCT00646087

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

June 6, 2011

Status Verified

June 1, 2011

First QC Date

March 25, 2008

Last Update Submit

June 3, 2011

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale.

    20 weeks

Secondary Outcomes (1)

  • Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact.

    20 weeks

Study Arms (2)

Ketamine (6K)

EXPERIMENTAL

6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days

Drug: Ketamine

Ketamine/Placebo (2K4P)

ACTIVE COMPARATOR

2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.

Drug: Ketamine/Saline

Interventions

KetamineDRUG

0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)

Ketamine (6K)
Ketamine/SalineDRUG

0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11

Ketamine/Placebo (2K4P)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Related Publications (21)

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

    PMID: 11310818BACKGROUND

  • 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.

    PMID: 16490412BACKGROUND

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

    PMID: 2112132BACKGROUND

  • 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.

    PMID: 7930496BACKGROUND

  • 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.

    PMID: 12444808BACKGROUND

  • 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.

    PMID: 10686270BACKGROUND

  • 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.

    PMID: 16533209BACKGROUND

  • 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.

    PMID: 12088953BACKGROUND

  • 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.

    PMID: 16894061BACKGROUND

  • 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.

    PMID: 8942324BACKGROUND

  • 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.

    PMID: 14684451BACKGROUND

  • 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.

    PMID: 16305457BACKGROUND

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

    PMID: 11759641BACKGROUND

  • 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.

    PMID: 15367304BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 4412100BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 9479681BACKGROUND

  • 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.

    PMID: 14399272BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Micheal Messer, MD

    Essentia Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

March 1, 2008

Last Updated

June 6, 2011

Record last verified: 2011-06

Locations

US(1)