Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02911597
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2016-04-23
Brief Title:
Double-Blind Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression TRD
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Double-Blind Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression TRD
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ket_Nal
Brief Summary:
The primary objective is to determine if the opioid properties of ketamine are responsible for its antidepressant effects Since naltrexone can block opiate actions the investigators will determine if naltrexone can effectively block ketamines effects
Detailed Description:
The primary goal is to determine if the antidepressant effects of Ketamine are mediated by an opiate mechanism
Primary Objective
To determine if the opioid properties of Ketamine are responsible for its antidepressant effects by potentially blocking the antidepressant effects with a opioid antagonist naltrexone
We will measure this objective by looking at the response on a scale called the 6- item Hamilton Rating Scale for Depression HAM-D-6 Response is defined as a statistically significant greater decrease on the overall score on this scale post infusion
Secondary Objective
This includes comparing a scale called Clinician Administered Dissociative States Scale CADSS on both of our patient groups one group receiving Ketamine plus Naltrexone compared to the other group receiving Ketamine plus placebeo to determine if naltrexone has any effect on CADSS as well as to determine if CADSS is associated with antidepressant response
Another secondary objective is to assess ketamine craving using the Visual Analog Craving Scale for Ketamine VASK after infusion and determine if there is a change in level of craving for the group that receives naltrexone
Number of Subjects
i 30
ii The subjects will be drawn from an outpatient sample of patients with MDD diagnosed with the use of the Structured Clinical Interview for DSM-IV Axis I DisordersSCID-IP currently on a stable adequate dose of antidepressant therapy as defined by the MGH ATRQ for at least 4 weeks or a history of intolerance to at least 2 antidepressant treatments
Primary Objective
To determine if the opioid properties of Ketamine are responsible for its antidepressant effects by potentially blocking the antidepressant effects with a opioid antagonist naltrexone
We will measure this objective by looking at the response on a scale called the 6- item Hamilton Rating Scale for Depression HAM-D-6 Response is defined as a statistically significant greater decrease on the overall score on this scale post infusion
Secondary Objective
This includes comparing a scale called Clinician Administered Dissociative States Scale CADSS on both of our patient groups one group receiving Ketamine plus Naltrexone compared to the other group receiving Ketamine plus placebeo to determine if naltrexone has any effect on CADSS as well as to determine if CADSS is associated with antidepressant response
Another secondary objective is to assess ketamine craving using the Visual Analog Craving Scale for Ketamine VASK after infusion and determine if there is a change in level of craving for the group that receives naltrexone
Number of Subjects
i 30
ii The subjects will be drawn from an outpatient sample of patients with MDD diagnosed with the use of the Structured Clinical Interview for DSM-IV Axis I DisordersSCID-IP currently on a stable adequate dose of antidepressant therapy as defined by the MGH ATRQ for at least 4 weeks or a history of intolerance to at least 2 antidepressant treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None