Depression
Conditions
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.
Interventions
DRUGKetamine
Intravenous ketamine 0.5mg/kg over 40 minutes
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS, HAM-D) | 48 hours | Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine All participants receive open-label ketamine
Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Didn't meet I/E criteria | 4 |
Baseline characteristics
| Characteristic | Ketamine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 48.3 years |
| HAMD Total Score | 28.5 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Hamilton Depression Rating Scale (HDRS, HAM-D)
Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.
Time frame: 48 hours
Population: Patients who completed the study. Outcome measure was at 48 hours.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Hamilton Depression Rating Scale (HDRS, HAM-D) | 11.5 units on a scale |