Trial Outcomes & Findings for Ketamine Infusion for Treatment-resistant Major Depressive Disorder (NCT NCT01582945)
NCT ID: NCT01582945
Last Updated: 2017-04-20
Results Overview
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.
COMPLETED
NA
14 participants
Weekly for total duration of 4 months
2017-04-20
Participant Flow
Patients were referred to the study by their primary psychiatrists and no compensation was provided for participation.
Subjects underwent a psychiatric screening evaluation, physical exam, EKG, laboratory testing, and a urine screening for substances of abuse to determine study eligibility.
Participant milestones
| Measure |
Treatment-resistant Depression Patients
Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment-resistant Depression Patients
Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
|
|---|---|
|
Overall Study
Intolerable side-effects
|
1
|
|
Overall Study
Scheduling conflicts
|
1
|
Baseline Characteristics
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Treatment-resistant Depression Patients
n=14 Participants
Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
|
Hamilton Rating Scale for Depression
|
28.6 units on a scale
STANDARD_DEVIATION 4.8 • n=99 Participants
|
PRIMARY outcome
Timeframe: Weekly for total duration of 4 monthsPopulation: The subjects received a total of 6 infusions, twice a week for three weeks.
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.
Outcome measures
| Measure |
Ketamine IV
n=12 Participants
Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.
Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
|
|---|---|
|
Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
|
5 participants who met response criteria
|
Adverse Events
Ketamine IV
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place