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Intravenous Ketamine Effects on Functional Neuroanatomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205890
Recruitment Status : Withdrawn (Sponsor is no longer interested in funding the study)
First Posted : December 20, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Neurological Associates of West Los Angeles

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 20, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE May 2, 2020
Actual Primary Completion Date May 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • fMRI T1 baseline [ Time Frame: Images to be acquired 7 days prior to Ketamine intervention ]
    T1-data was collected as a sagittal MPRAGE sequence. T1 images are corrected for field biasing and then skull stripped and linearly registered to standard MNI space. Each patients' T1 image is segmented into 100 cortical and 15 subcortical areas using the Harvard-Oxford Cortical and Subcortical structural atlas. Mean volume is computed for each of these regions for each patient, which can be used for quantitative comparison.
  • fMRI T1 post-intervention comparison [ Time Frame: Images to be acquired at 2 days post-treatment ]
    T1-data was collected as a sagittal MPRAGE sequence. T1 images are corrected for field biasing and then skull stripped and linearly registered to standard MNI space. Each patients' T1 image is segmented into 100 cortical and 15 subcortical areas using the Harvard-Oxford Cortical and Subcortical structural atlas. Mean volume is computed for each of these regions for each patient, which can be used for quantitative comparison.
  • Arterial Spin Labeling (fMRI) baseline [ Time Frame: Images to be acquired 7 days prior to Ketamine intervention ]
    Pulsed Arterial Spin Labeling is collected as an echo planar sequence. ASL data is superimposed over the acquired T1-weighted brain image demonstrating a map of cerebral perfusion. Quantification to CBF values (milliliters of blood per 100g of tissue per minute) is implemented and voxel-based comparisons showing perfusion values relative to the acquired data range are used for quantification.
  • Arterial Spin Labeling (fMRI) post-intervention comparison [ Time Frame: Images to be acquired at 2 days post-treatment ]
    Pulsed Arterial Spin Labeling is collected as an echo planar sequence. ASL data is superimposed over the acquired T1-weighted brain image demonstrating a map of cerebral perfusion. Quantification to CBF values (milliliters of blood per 100g of tissue per minute) is implemented and voxel-based comparisons showing perfusion values relative to the acquired data range are used for quantification.
  • fMRI Resting Bold baseline [ Time Frame: Images to be acquired 7 days prior to Ketamine intervention ]
    The signal change measured in BOLD imaging comes from the brain oversupplying the region of activation with oxygen, leading to a focal decrease in deoxygenated hemoglobin. Processed BOLD imaging allows for visualization of hemodynamic response (HR) and neurovascular coupling (NVC) based on signal variability and distribution. These elements can be quantified and used for comparison.
  • fMRI Resting Bold post-intervention comparison [ Time Frame: Images to be acquired at 2 days post-treatment ]
    The signal change measured in BOLD imaging comes from the brain oversupplying the region of activation with oxygen, leading to a focal decrease in deoxygenated hemoglobin. Processed BOLD imaging allows for visualization of hemodynamic response (HR) and neurovascular coupling (NVC) based on signal variability and distribution. These elements can be quantified and used for comparison.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • Beck Depression Inventory [ Time Frame: 7 days prior to treatment ]
    The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
  • Beck Depression Inventory [ Time Frame: Day of treatment ]
    The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
  • Beck Depression Inventory [ Time Frame: 2 days after treatment ]
    The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
  • Beck Anxiety Inventory [ Time Frame: 7 days prior to treatment ]
    The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
  • Beck Anxiety Inventory [ Time Frame: Day of treatment ]
    The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
  • Beck Anxiety Inventory [ Time Frame: 2 days after treatment ]
    The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
  • Brief Pain Inventory [ Time Frame: 7 days prior to treatment ]
    Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
  • Brief Pain Inventory [ Time Frame: Day of Treatment ]
    Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
  • Brief Pain Inventory [ Time Frame: 2 days post-treatment ]
    Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Ketamine Effects on Functional Neuroanatomy
Official Title  ICMJE Intravenous Ketamine Effects on Functional Neuroanatomy
Brief Summary The purpose of this study is to investigate the neuroanatomical effects of ketamine treatment on patients with treatment-resistant depression. The investigators will compare the neuroimaging of patients several days before and after injection in order to assess the more durable changes induced by ketamine. In addition, changes in perfusion will be analyzed, in addition to changes in neurovascular coupling, and functional connectivity that are correlated with psychiatric measures.
Detailed Description

The present study is designed as a prospective data analysis of patient response to the use of ketamine to treat treatment-resistant depression. For Phase I trail, 10 patients of any gender with an age range of 18 to 70 who have undergone the outlined procedure will be recruited for inclusion. Patients will be examined by the principle investigator. All patients must be diagnosed with persistent treatment-resistant depression and prescribed ketamine. Patients will be accepted regardless of if the depression coincided with anxiety and/or pain. Patient status will be assessed using the Beck Depression Inventory, Beck Anxiety Inventory, and Brief Pain Inventory. Patients must have a Beck Depression Inventory score of 10 or above. These scores will be used as baseline data. Patients will be offered the option of participating in the study and provided informed consent for neuroimaging before and after the ketamine treatment.

A week before the scheduled ketamine treatment, the patients will have fMRI scans, including structural T1, Arterial Spin Labeling, and Resting BOLD. The scans take around 30 minutes at no charge to the patients. The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosages varies between 75mg - 1000mg depending on every individual's unique treatment plan. The same scans will be taken two days after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The purpose of this study is to investigate the neuroanatomical effects of ketamine treatment on patients with treatment-resistant depression. We will compare the neuroimaging of patients several days before and after injection in order to assess the more durable changes induced by ketamine. We will analyze changes in perfusion, neurovascular coupling, and functional connectivity that are correlated with psychiatric measures.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Drug: Ketamine
The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosage varies between 75mg - 1000mg depending on every individual's unique treatment plan.
Study Arms  ICMJE Experimental: Ketamine
The present study is designed as a prospective data analysis of patient response to the use of ketamine to treat treatment-resistant depression. For Phase I trail, 10 patients of any gender with an age range of 18 to 70 who have undergone the outlined procedure will be recruited for inclusion. A week before the scheduled ketamine treatment, the patients will have fMRI scans, including structural T1, Arterial Spin Labeling, and Resting BOLD. The scans take around 30 minutes at no charge to the patients. The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosage will vary (see below) depending on every individual's unique treatment plan. The same scans will be taken two days after treatment.
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2019)
10
Actual Study Completion Date  ICMJE May 28, 2020
Actual Primary Completion Date May 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In order for a subject to be considered for this study, the patient must have been diagnosed with treatment-resistant depression, meaning the patient failed three medications and has been suffering from moderate treatment-resistant depression for over 6 months, indicated by a Beck Depression Inventory score of 10 or above. The patient must have been prescribed ketamine as part of their treatment plan, completely independent of any research. The patient must be willing to comply with the study protocol.

Exclusion Criteria:

  • In order for a subject to be considered for this study, he/she may not have any of the following:

    • Advanced stages of any terminal illness or any active cancer that requires chemotherapy
    • Hepatic impairment
    • Significant cytopenia
    • Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
    • Women who are pregnant, may become pregnant, or are breastfeeding
    • Any counter indications to ketamine
    • Subjects unable to give informed consent or in vulnerable categories, such as prisoners
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04205890
Other Study ID Numbers  ICMJE 20190792
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.
Responsible Party Neurological Associates of West Los Angeles
Study Sponsor  ICMJE Neurological Associates of West Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sheldon Jordan, MD The Neurological Associates of West Los Angeles
Principal Investigator: Taylor Kuhn, PhD The Neurological Associates of West Los Angeles
PRS Account Neurological Associates of West Los Angeles
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP