Charleston, South Carolina 29403

  • Major Depressive Disorder

Purpose:

The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.


Criteria:

Inclusion Criteria A subject may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first experimental session: 1. Between the ages of 18 to 64 years old. 2. Able to provide informed consent. 3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview. 4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression). 5. Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview. 6. Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation. Exclusion Criteria Subjects will be excluded from the study if any of the following criteria apply: 1. They are considered an immediate suicide risk by clinician assessment, self-reports a suicide attempt within the past year, or felt to be likely to require hospitalization during the study. 2. Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview. 3. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview. 4. Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder. 5. Subjects who report use of ketamine >20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission. 6. Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the interventional phase of the study. 7. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg. 8. A history of allergic or other adverse reaction to ketamine (or its excipients). 9. Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease). 10. QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded. 11. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study. 12. Subjects with kidney or liver impairment.


Study is Available At:


Original ID:

Pro00115696


NCT ID:

NCT05193318


Secondary ID:


Study Acronym:

KReDO


Brief Title:

KAP for Depression in Abstinent Opioid Users


Official Title:

Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Eric T Dobson, MD
Principal Investigator
Medical University of South Carolina
Primary Contact:Eric T Dobson, MD
843-729-1445
dobsoner@musc.edu

Study Dates

Start Date:January 13, 2022
Completion Date:June 30, 2022
Completion Type:Anticipated
Primary Completion Date:June 30, 2022
Primary Completion Type:Anticipated
Verification Date:February 2022
Last Changed Date:February 23, 2022
First Received Date:December 14, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Montgomery Asberg Depression Rating Scale
Time Frame:Change from baseline measured at week 9
Safety Issues:False
Description:Clinician-administered rating of depressive symptoms; minimum score of 0, maximum score of 60; a decrease in score means a better outcome (less depressed)
Outcome Type:Secondary Outcome
Measure:Beck Depression Inventory
Time Frame:Change from baseline measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
Outcome Type:Secondary Outcome
Measure:Visual Analog Scale (VAS)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Measure of subjective level of opioid craving; maximum score of 100 and minumum score of 0 with higher scores meaning worse outcome (more cravings)
Outcome Type:Secondary Outcome
Measure:Generalized Anxiety Disorder-7 (GAD-7)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)
Outcome Type:Secondary Outcome
Measure:Mystical Experience Questionnaire (MEQ)
Time Frame:Measured at week 1-8
Safety Issues:False
Description:Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense experience
Outcome Type:Secondary Outcome
Measure:Brief Pain Inventory (BPI)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Measure of pain and quality of life; maximum score of 10 and minimum of 1 with higher scores indicating worse outcome (more pain)
Outcome Type:Secondary Outcome
Measure:Insomnia Severity Index (ISI)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Assesses insomnia and sleep quality; maximum score of 28 and minimum score of 0 with higher score indicating worse outcome (worse sleep)
Outcome Type:Secondary Outcome
Measure:Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Assesses aspects of mindfulness; maximum score of 40 and minimum score of 8 with higher scores indicating better outcome (more mindfulness)
Outcome Type:Secondary Outcome
Measure:PTSD Checklist (PCL-5; PTSD checklist 5)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)
Outcome Type:Secondary Outcome
Measure:Timeline Follow-back (TLFB)
Time Frame:Measured at week 1-9, 10, 12, and 16
Safety Issues:False
Description:Measure of Substance Use; maximum number of substance use days per week is 7 and minimum is 0 with higher number indicating worse outcomes (more substance use)
Outcome Type:Secondary Outcome
Measure:Montgomery Asberg Depression Rating Scale
Time Frame:Change from baseline measured at week 2-8, 10, 12, and 16
Safety Issues:False
Description:Clinician-administered rating of depressive symptoms; minimum score of 0, maximum score of 60; a decrease in score means a better outcome (less depressed)

Study Interventions

Intervention Type:Drug
Name:Ketamine-assisted psychotherapy
Description:Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Arm Name:Ketamine-assisted psychotherapy

Study Arms

Study Arm Type:Experimental
Arm Name:Ketamine-assisted psychotherapy
Description:Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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