Ketamine Frequency Treatment for Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT00646087 |
Recruitment Status :
Withdrawn
(Pilot study determined that this study would not be feasible.)
First Posted : March 28, 2008
Last Update Posted : June 6, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Treatment Resistant Depression | Drug: Ketamine Drug: Ketamine/Saline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ketamine Frequency Treatment for Major Depressive Disorder |
Study Start Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Ketamine (6K)
6K: 6 ketamine injections (0.5 mg/kg of ketamine) every other day for 12 days
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Drug: Ketamine
0.5 mg/kg of ketamine every other day for 12 days (days 1, 3, 5, 7, 9, 11) |
Active Comparator: Ketamine/Placebo (2K4P)
2K4P = two active ketamine injections(2K) and four placebo (saline) injections over 12 days.
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Drug: Ketamine/Saline
0.5 mg/kg of ketamine on days 1 and 7, placebo (saline) on days 3, 5, 9, 11 |
- The primary efficacy measure is the change in scores in the 21-item Hamilton Depression Rating Scale. [ Time Frame: 20 weeks ]
- 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 ]

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646087
United States, Minnesota | |
St. Mary's Duluth Clinic Health System | |
Duluth, Minnesota, United States, 55805 |
Principal Investigator: | Micheal Messer, MD | Essentia Health |
Publications:
Responsible Party: | Micheal Messer MD, St. Mary's Duluth Clinic Health System |
ClinicalTrials.gov Identifier: | NCT00646087 History of Changes |
Other Study ID Numbers: |
04-07-04 |
First Posted: | March 28, 2008 Key Record Dates |
Last Update Posted: | June 6, 2011 |
Last Verified: | June 2011 |
Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mood Disorders Mental Disorders Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |