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WithdrawnPhase 4

Ketamine Frequency Treatment for Major Depressive Disorder

NCT00646087 · Essentia Health

Closed to entry
Status
Not accepting participants
Phase 4
Phase
—
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 20 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

30 Years to 65 Years
Ages
All
Sex
Accepted
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

Where

1 study site

FacilityCityRegionCountry
St. Mary's Duluth Clinic Health SystemDuluthMinnesotaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT00646087 on ClinicalTrials.gov →

Last updated in the registry 2011-06-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in