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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Subject will receive 6 infusions of ketamine over three weeks. |
|
| Placebo | Placebo Comparator | Subjects will receive 6 infusions of normal saline over 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Cusin, M.D. | MGH Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Clinical and Reseach Program - MGH | Boston | Massachusetts | 02114 | United States |
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Outpatients were recruited primarily through referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo |
| FG002 | Screen Fail/No Baseline | Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria. Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | up to 4 months |
|
up to 3 months
Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated hospitalization | Infections and infestations | Non-systematic Assessment | The subject was hospitalized due to syncope. This event very unlikely related to the study medication, due to the significant time delay between the final infusion and the episodes of syncope. The most probable explanation is a viral infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ketamine side effects | General disorders | Non-systematic Assessment | Including dizziness, fever, fainting, and detachment from reality |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cristina Cusin | Massachusetts General Hospital | 6177263855 | ccusin@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug |
|
| Time committment |
|
| Inclusion/Exclusion Criteria |
|
| Lost to Follow-up |
|
| Side effects |
|
Subjects will receive 6 infusions of normal saline over 3 weeks.
Placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | up to 5 months |
|
|
|
| 2 |
| 13 |
| 3 |
| 13 |
| EG001 | Placebo | Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo | 0 | 13 | 1 | 13 |
|
| Worsening Depression | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized due to worsening depression and suicidal ideation. Study team was notified by the participant via phone call or email. |
|
|
| Psychiatric Hospitalization | Psychiatric disorders | Non-systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Blood Pressure elevated | General disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |