Ketamine Frequency Treatment for Major Depressive Disorder | NCT00646087

Studies
Ketamine Frequency Treatment for Major Depressive Disorder

NCT00646087

Sponsor

Essentia Health

Status

Withdrawn

Last Update Posted

Jun 6, 2011Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Treatment Resistant Depression

Interventions

Ketamine
Ketamine/Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Pilot study determined that this study would not be feasible.

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 27, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2011

Last Update Posted Date

Jun 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11)	Ketamine (6K)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale.		20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with remission (HDRS score < 18) at the end of the 2-week treatment and each follow-up contact.		20 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Micheal Messer, MD	Essentia Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Mary's Duluth Clinic Health System		Duluth	Minnesota	55805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11310818	Background	Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9.
16490412	Background	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.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D007649	Ketamine
D012965	Sodium Chloride

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic