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Ketamine Frequency Treatment for Major Depressive Disorder

Primary Purpose

Treatment Resistant Depression

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Ketamine/Saline

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

St. Mary's Duluth Clinic Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine (6K)

Ketamine/Placebo (2K4P)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00646087

First Posted

March 25, 2008

Last Updated

June 3, 2011

Sponsor

Essentia Health

1. Study Identification

Unique Protocol Identification Number

NCT00646087

Brief Title

Ketamine Frequency Treatment for Major Depressive Disorder

Official Title

Ketamine Frequency Treatment for Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Pilot study determined that this study would not be feasible.

Study Start Date

March 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Essentia Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine (6K)

Arm Type

Experimental

Arm Description

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

Arm Title

Ketamine/Placebo (2K4P)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine/Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Micheal Messer, MD

Organizational Affiliation

Essentia Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Mary's Duluth Clinic Health System

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

12. IPD Sharing Statement

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Ketamine Frequency Treatment for Major Depressive Disorder

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