Ketamine Frequency Treatment for Major Depressive Disorder

Essentia Health

Status and phase: Withdrawn; Phase 4

Conditions: Treatment Resistant Depression

Treatments: Drug: Ketamine/Saline; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00646087

04-07-04

Details and patient eligibility

About

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.

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Ketamine (6K)

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Ketamine/Placebo (2K4P)

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine/Saline