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Ketamine Frequency Treatment for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00646087
Recruitment Status : Withdrawn (Pilot study determined that this study would not be feasible.)
First Posted : March 28, 2008
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Essentia Health

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE March 28, 2008
Last Update Posted Date June 6, 2011
Study Start Date  ICMJE March 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale. [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
· 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Frequency Treatment for Major Depressive Disorder
Official Title  ICMJE Ketamine Frequency Treatment for Major Depressive Disorder
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE
  • Drug: Ketamine
    0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)
  • Drug: Ketamine/Saline
    0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11
Study Arms  ICMJE
  • Experimental: Ketamine (6K)
    6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days
    Intervention: Drug: Ketamine
  • Active Comparator: Ketamine/Placebo (2K4P)
    2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.
    Intervention: Drug: Ketamine/Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 3, 2011)
0
Original Actual Enrollment  ICMJE
 (submitted: March 27, 2008)
2
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00646087
Other Study ID Numbers  ICMJE 04-07-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Micheal Messer MD, St. Mary's Duluth Clinic Health System
Study Sponsor  ICMJE Essentia Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Micheal Messer, MD Essentia Health
PRS Account Essentia Health
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP