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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00646087
First received: March 25, 2008
Last updated: June 3, 2011
Last verified: June 2011
  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:


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
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:
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.
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.
Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. Feb 1960;23:56-62.
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

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 July 22, 2014