Clinical trial NCT03053830: Open Label Ketamine Treatment for Major Depressive Disorder in Veterans
Official title: An Open Label Study of the Effects of Ketamine on a Veteran Clinical Population With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Ketamine
Major Depressive Disorder
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2017-02-15
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer term effects of ketamine.

Detailed description: A total of 25 depressed subjects between the ages of 21-75 who have current major depressive disorder without psychotic features by DSM-5 will be recruited. Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments. Patients will be recruited in outpatient settings to the Refractory Depression Clinic. Providers or Refractory Depression consult team will be informed if the patient may be eligible for participation in the ketamine protocol. Subjects must have established care in the VA Connecticut Healthcare System. If the Veteran is interested, a screening visit for further evaluation for the ketamine protocol will be scheduled. Veterans will receive up to 6 infusions for ketamine weekly, per PI discretion. The primary goal of this proposal is to test the effectiveness of repeated ketamine treatment (0.5 mg/kg; once or twice a week for up to 6 weeks; up to a total of 6 ketamine infusions). An open-label trial will be conducted that will include up to 25 Veterans with MDD with a follow-up of 6 months. This open-label trial will allow us to examine the safety and tolerability of the ketamine treatment in this population and the long-term effects. All patients will receive usual standard care during this trial.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 21-75 years old
2. Current major depressive disorder without psychotic features by DSM-5
3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
4. Able to provide written informed consent

Exclusion Criteria:

1. Current or past history of psychotic features or psychotic disorder
2. Current or past history of delirium or dementia
3. Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
4. Unstable medical condition or allergy to ketamine or lorazepam---clinically determined by a physician
5. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
6. Positive opioid or illicit drug screen test (except marijuana)

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 40 mins after infusion, 140 mins after infusion, 240 mins after infusion
measure: Change in Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR)
timeFrame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 240 mins after infusion
measure: Change in Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Frame: Baseline, 40 mins after infusion,140 mins after infusion, 240 mins after infusion
measure: Clinical Global Impression Scale
timeFrame: Baseline
measure: Change in Brief Psychotic Rating Scale (BPRS)
timeFrame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
measure: Change in Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
measure: Change in Visual Analog Scale (VAS) of Mood States
timeFrame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
measure: Time Line Follow Back (TLFB)
timeFrame: Baseline
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline
measure: Quality of life enjoyment and satisfaction survey (Q-LES-Q)
timeFrame: Baseline
measure: Cognition
timeFrame: 140 mins after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Healthcare System
state: Connecticut
Study officials:
References: