Major Depressive Disorder
Conditions
Brief summary
Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.
Interventions
DRUGKetamine
ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
DRUGPlacebo
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Outpatient with sever treatment resistant depression * Currently depressed * Currently under regular psychiatric care * On an aggressive antidepressant regimen, stable for 4 weeks.
Exclusion criteria
* No history of other major psychiatric illness, including bipolar * No history of psychosis * No history of drug abuse * No major medical illness or unstable medical problem
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) | up to 4 months | The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDRS-28 Total | up to 5 months | Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission. |
Countries
United States
Participant flow
Recruitment details
Outpatients were recruited primarily through referrals.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Subject will receive 6 infusions of ketamine over three weeks.
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen. | 13 |
| Placebo Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Inclusion/Exclusion Criteria | 0 | 0 | 5 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Side effects | 3 | 0 | 0 |
| Overall Study | Time committment | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Ketamine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Continuous | 45.3 years STANDARD_DEVIATION 11.7 | 45.5 years STANDARD_DEVIATION 13.6 | 45.4 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 13 | 1 / 13 |
| serious Total, serious adverse events | 2 / 13 | 0 / 13 |
Outcome results
Primary
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.
Time frame: up to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) | 1.6 units on a scale | Standard Deviation 1.4 |
| Placebo | Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI) | 1.6 units on a scale | Standard Deviation 1.4 |
Secondary
HDRS-28 Total
Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.
Time frame: up to 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | HDRS-28 Total | 20.2 units on a scale | Standard Deviation 11.1 |
| Placebo | HDRS-28 Total | 20.0 units on a scale | Standard Deviation 10.7 |