Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects

NCT ID: NCT02669043

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-02-28

Brief Summary

Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of depression within hours in many patients with "treatment-resistant" depression, has been associated with superior efficacy in those individuals with anxious compared with non-anxious depression. In order to understand this unique effect more fully, the current protocol is aimed at further delineating biomarkers of ketamine's effects among individuals with treatment-resistant anxious depression compared to those with nonanxious depression.

Conditions

Depression

Study Design

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

Study Groups

Ketamine

All participants receive open-label ketamine

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Intravenous ketamine 0.5mg/kg over 40 minutes

Interventions

Ketamine

Intravenous ketamine 0.5mg/kg over 40 minutes

Intervention Type: DRUG

Other Intervention Names

Ketamine Hydrochloride

Eligibility Criteria

Inclusion Criteria

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 (MDD) for ≥ 4 weeks,

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

5. be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,

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

7. have a reliable chaperone to 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).

Exclusion Criteria

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 (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure >140/95 mmHg at Screening,

4. history of multiple adverse drug reactions,

5. current/past history of psychotic disorders, history of out-of-body feelings or derealization,

6. active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP (phencyclidine) abuse (we will confirm this with collateral information from their doctor if necessary),

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

8. caffeine or nicotine use within 1 hour of psychophysiology testing, or alcohol use within 1 day of testing,

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

10. clinically significant hearing impairment,

11. current serious suicidal or homicidal risk,

12. concurrent participation in other research studies involving medications or other treatments,

13. narrow angle glaucoma,

14. acute intermittent porphyria history,

15. history of seizures in the past 6 months, regardless of seizure type,

16. hyperthyroidism or untreated hypothyroidism,

17. airway instability or pulmonary disease with hypercarbia, or

18. current or past cubital or carpal tunnel syndrome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cristina Cusin, MD

Assistant in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Ionescu, 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

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH107776

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015P002397

Identifier Type: -

Identifier Source: org_study_id