Ketamine Frequency Treatment for Major Depressive Disorder

Phase 4

Withdrawn

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Ketamine/Saline; Drug: Ketamine

• Registration Number: NCT00646087
• Lead Sponsor: Essentia Health

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 available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine/Placebo (2K4P)	Ketamine/Saline	2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.
Ketamine (6K)	Ketamine	6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Mary's Duluth Clinic Health System; 🇺🇸 Duluth, Minnesota, United States