Major Depressive Disorder
Conditions
Keywords
Treatment resistant, suicidal ideation, major depressive disorder
Brief summary
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD). This is an open-label study (pilot).
Detailed description
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months. Total duration of the study is 5 months.
Interventions
DRUGKetamine
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients with severe treatment-resistant MDD * Currently depressed * Currently under regular psychiatric care * On an aggressive antidepressant regimen, stable for 4 weeks
Exclusion criteria
* No history of other major psychiatric illnesses, including bipolar disorder * No history of psychosis * No history of drug abuse * No major medical illness or unstable medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) | Weekly for total duration of 4 months | Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28. |
Countries
United States
Participant flow
Recruitment details
Patients were referred to the study by their primary psychiatrists and no compensation was provided for participation.
Pre-assignment details
Subjects underwent a psychiatric screening evaluation, physical exam, EKG, laboratory testing, and a urine screening for substances of abuse to determine study eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Treatment-resistant Depression Patients Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD). | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Intolerable side-effects | 1 |
| Overall Study | Scheduling conflicts | 1 |
Baseline characteristics
| Characteristic | Treatment-resistant Depression Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 50.0 years STANDARD_DEVIATION 7.8 |
| Hamilton Rating Scale for Depression | 28.6 units on a scale STANDARD_DEVIATION 4.8 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
Time frame: Weekly for total duration of 4 months
Population: The subjects received a total of 6 infusions, twice a week for three weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketamine IV | Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) | 5 participants who met response criteria |