total score on the 17-item Hamilton Depression Rating Scale
Endogenous Opioid Modulation by Ketamine
Brief Summary
Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.
Intervention / Treatment
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Ketamine Hydrochloride (DRUG)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.
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Normal saline (OTHER)Placebo
Condition or Disease
- Major Depressive Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Withdrawn |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 0 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Basic Science |
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Clinical Trial Dates
| Start date: | Aug 01, 2019 | ESTIMATED |
|---|---|---|
| Primary Completion: | Aug 01, 2019 | ACTUAL |
| Completion Date: | Aug 01, 2019 | ACTUAL |
| Study First Posted: | Feb 14, 2017 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 24, 2020 |
Sponsors / Collaborators
Lead Sponsor:
University of Utah
Responsible Party:
N/A
Location
This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.
Participant Groups
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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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Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
More Details
| NCT Number: | NCT03051945 |
|---|---|
| Other IDs: | 00087544 |
| Study URL: | https://clinicaltrials.gov/study/NCT03051945 |
Last updated: Sep 29, 2023