Endogenous Opioid Modulation by Ketamine
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ClinicalTrials.gov Identifier: NCT03051945 |
Recruitment Status :
Withdrawn
(Unable to perform brain imaging)
First Posted : February 14, 2017
Last Update Posted : January 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Ketamine Hydrochloride Other: Normal saline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Endogenous Opioid Modulation by Ketamine |
Estimated Study Start Date : | August 2019 |
Actual Primary Completion Date : | August 1, 2019 |
Actual Study Completion Date : | August 1, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Ketamine
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
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Drug: Ketamine Hydrochloride
Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances. |
Placebo Comparator: Placebo
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
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Other: Normal saline
Placebo |
- Hamilton Depression Rating Scale at 24 hours, change from baseline [ Time Frame: 24 hr ]total score on the 17-item Hamilton Depression Rating Scale

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65
- DSM-5 major depressive disorder
- Current moderate-to-severe, treatment-resistant, depressive episode
- Patient Health Questionnaire (PHQ-9) total score ≥ 10
- PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
- PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
- Medical documentation of depression for at least 2 months
- Inadequate response to at least one adequate antidepressant medication trial in the current episode
Exclusion Criteria:
- Current episode duration >5 years
- Moderate-to-severe DSM-5 substance use disorder (past year)
- Cognitive disorder (past year)
- Post-traumatic stress disorder (past year)
- Obsessive compulsive disorder (past year)
- Personality disorder (past year)
- Positive urine drug screen
- Psychotic symptoms
- Mania
- Significant neurologic disorder or injury
- Breastfeeding or pregnancy
- Imminent suicide risk
- Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
- Other unstable psychiatric or medical condition requiring a higher level of care
- Contraindication to ketamine, MRI, or PET

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): NCT03051945
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 |
Responsible Party: | Brian Mickey, Principal Investigator, University of Utah |
ClinicalTrials.gov Identifier: | NCT03051945 |
Other Study ID Numbers: |
00087544 |
First Posted: | February 14, 2017 Key Record Dates |
Last Update Posted: | January 28, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Depressive Disorder Depressive Disorder, Major 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 |