Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

Major Depressive Disorder Clinical Trial

— Ket-MDD  

Official title:

An Open Label Study of the Effects of Ketamine on a Veteran Clinical Population With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053830
• Other study ID #: MR0012
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: September 2023
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Ketamine
0.5mg/kg ketamine in normal saline. Infusion will be delivered during a 40 minute interval

Locations

Country	Name	City	State
United States	VA Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS is a standardized instrument to ascertain depressed mood and neurovegetative signs and symptoms of a major depressive episode.	Baseline, 40 mins after infusion, 140 mins after infusion, 240 mins after infusion
Primary	Change in Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR)	A patient rated depression instrument	Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 240 mins after infusion
Primary	Change in Hamilton Anxiety Rating Scale (HAM-A)	Standardized instrument to evaluate anxiety severity	Frame: Baseline, 40 mins after infusion,140 mins after infusion, 240 mins after infusion
Primary	Clinical Global Impression Scale	Widely used instrument which asses overall severity of illness on a 1-7 point scale, with 1 indicating, not at all ill and 7 indicating among the most extremely ill patients	Baseline
Primary	Change in Brief Psychotic Rating Scale (BPRS)	The BPRS is a standardized instrument that contains scales assessing psychotic symptoms including positive and negative symptoms, activation and emotional distress.	Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
Primary	Change in Clinician-Administered Dissociative States Scale (CADSS)	The CADSS has self and interviewer-administered items including 5 subscales, generated a priori, evaluating dissociation including altered environmental perception, time perception, spatial/body perception, derealization and memory impairment.	Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
Primary	Change in Visual Analog Scale (VAS) of Mood States	The VAS includes scales for anxiety, drowsiness, high irritability, anger and sadness. The scales are 100 mm lines marked by subjects at a point corresponding to the apparent intensity of the feeling state (0 = none, to 100 = most ever).	Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion
Primary	Time Line Follow Back (TLFB)	The TLFB is a standardized measure utilized for collecting information on daily alcohol use as well as other substance use.	Baseline
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS has both lifetime/recent and since last visit versions. The "Lifetime/Recent" version gathers information on lifetime history of suicidality and recent suicidal ideation/self-injurious behavior. The "Since Last Visit" version of the C-SSRS asks about any suicidal thoughts or behaviors the subject has exhibited since the last time administered the C-SSRS.	Baseline
Primary	Quality of life enjoyment and satisfaction survey (Q-LES-Q)	The Q-LES-Q is a self-report measure of quality of life.	Baseline
Primary	Cognition	A standard computerized battery will be done to assess cognitive ability post treatment of ketamine. The battery will include a wide range on cognitive tasks including but not; limited to attention, learning, and working memory. While it is know ketamine causes acute cognitive effects, the longer-term effects of ketamine are not known. When the cognitive battery is being conducted on test days it will be done at the end of the test day, to eliminate the confounding effects of acute treatment of ketamine..	140 mins after infusion