Ketamine for Depression: An MRI Study

NCT02544607 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2015P00191224032
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.

Conditions

Depression; Anxious Depression; Major Depressive Disorder

Keywords

Ketamine; Depression; Anxious Depression; MRI

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.

  Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms Change will be calculated by difference between HDRS from Minute 0 to Minute 240.

  4 hours

Secondary Outcomes (4)

• Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)

  4 hours

• Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)

  4 hours

• Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)

  4 hours

• Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)

  4 hours

Study Arms (1)

Ketamine + MRI

EXPERIMENTAL

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Drug: Ketamine; Other: Magnetic Resonance Imaging (MRI)

Interventions

Ketamine DRUG

Ketamine 0.5mg/kg over 40 minutes IV

Also known as: Ketamine Hydrochloride

Ketamine + MRI

Magnetic Resonance Imaging (MRI) OTHER

MRI technology will be used before and after ketamine for patients with depression

Ketamine + MRI

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will:
• be 18-64 years old,
• read, understand, and provide written informed consent in English,
• meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks,
• have a history of ≥1 failed medication trial during the current depression
• be on a stable antidepressant and psychotherapy regimen for ≥28 days,
• maintain a treating doctor who is in agreement with study participation,
• have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
• be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
• be of non-childbearing potential or use of an acceptable form of birth control (females only),
• be right handed.

You may not qualify if:

• Patients will be excluded if any of the following criteria are met:
• \) delirium or dementia diagnosis, 2) unstable medical illness or clinically significant laboratory results, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury), 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders, 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse, 7) requirement of excluded medications that may interact with ketamine, 8) weigh \>250 lbs., 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only) 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 11) current serious suicidal or homicidal risk, or 12) concurrent participation in other research studies.
• \---------------------------------------------------------------------------------------
• Healthy Controls will:
• be 18-64 years old,
• read, understand, and provide written informed consent in English,
• have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
• be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
• be of non-childbearing potential or use of an acceptable form of birth control (females only), and
• be right handed.
• Healthy controls will be excluded if any of the following criteria are met:
• current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
• presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
• presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),
• requirement of excluded medications that may interact with ketamine,

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brain & Behavior Research Foundation: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• MGH Depression Clinical and Research Program

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Ketamine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Cristina Cusin
• Organization: Massachusetts General Hospital

ccusin@mgh.harvard.edu

617-726-6421

Study Officials

• Cristina Cusin, M.D.

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cristina Cusin, M.D.

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: March 1, 2016
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)