Ketamine for Depression: An MRI Study

NCT ID: NCT02544607

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-12-29

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.

Detailed Description

Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS). MRI data will also be analyzed to examine the extent to which certain brain areas predict ketamine's antidepressant effects.

Conditions

Depression; Anxious Depression; Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ketamine + MRI

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Ketamine 0.5mg/kg over 40 minutes IV

Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

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

Interventions

Ketamine

Ketamine 0.5mg/kg over 40 minutes IV

Intervention Type: DRUG

Magnetic Resonance Imaging (MRI)

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

Intervention Type: OTHER

Other Intervention Names

Ketamine Hydrochloride

Eligibility Criteria

Inclusion Criteria

Patients will:

1. be 18-64 years old,

2. read, understand, and provide written informed consent in English,

3. meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks,

4. have a history of ≥1 failed medication trial during the current depression

5. be on a stable antidepressant and psychotherapy regimen for ≥28 days,

6. maintain a treating doctor who is in agreement with study participation,

7. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,

8. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),

9. be of non-childbearing potential or use of an acceptable form of birth control (females only),

10. be right handed.

Healthy Controls will:

1. be 18-64 years old,

2. read, understand, and provide written informed consent in English,

3. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,

4. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),

5. be of non-childbearing potential or use of an acceptable form of birth control (females only), and

6. be right handed.

Exclusion Criteria

Patients will be excluded if any of the following criteria are met:

1) 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.

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Healthy controls will be excluded if any of the following criteria are met:

1. current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),

2. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),

3. presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),

4. requirement of excluded medications that may interact with ketamine,

5. presence of psychiatric disorders in first-degree relatives,

6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or

7. weight >250 lbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cristina Cusin, MD

Cristina Cusin, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Cusin, M.D.

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.depressionmgh.org/our-studies

MGH Depression Clinical and Research Program

Other Identifiers

24032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2015P001912

Identifier Type: -

Identifier Source: org_study_id