Ketamine Frequency Treatment for Major Depressive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

January 22, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00646087 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

· 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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%.

In this pilot study we will assess the feasibility of conducting a randomized clinical trial that will examine the frequency of treatment with ketamine in patients with TDR 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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Treatment Resistant Depression

Intervention ^ICMJE

Drug: Ketamine

Study Arms / Comparison Groups

Active Comparator: patients will receive either 0.5 mg/kg of ketamine every other day for 12 days vs. two active and four placebo treatments over 12 days.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00646087

Responsible Party

Micheal Messer MD, St. Mary's Duluth Clinic Health System

Study ID Numbers ^ICMJE

04-07-04

Study Sponsor ^ICMJE

St. Mary's Duluth Clinic Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Micheal Messer, MD

St. Mary's Duluth Clinic Health System

Information Provided By

St. Mary's Duluth Clinic Health System

Verification Date

March 2008

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