ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans (Ket-MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03053830
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, VA Connecticut Healthcare System

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Ketamine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Effects of Ketamine on a Veteran Clinical Population With Major Depressive Disorder (MDD)
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intervention Group
Veterans with Major Depressive Disorder getting up to 6 infusions of 0.5mg/kg ketamine in normal saline; one infusion per week, 40 minutes per infusion with time points lasting up to 5 hours.
Drug: Ketamine
0.5mg/kg ketamine in normal saline. Infusion will be delivered during a 40 minute interval




Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, 40 mins after infusion, 140 mins after infusion, 240 mins after infusion ]
    MADRS is a standardized instrument to ascertain depressed mood and neurovegetative signs and symptoms of a major depressive episode.

  2. Change in Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR) [ Time Frame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 240 mins after infusion ]
    A patient rated depression instrument

  3. Change in Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Frame: Baseline, 40 mins after infusion,140 mins after infusion, 240 mins after infusion ]
    Standardized instrument to evaluate anxiety severity

  4. Clinical Global Impression Scale [ Time Frame: Baseline ]
    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

  5. Change in Brief Psychotic Rating Scale (BPRS) [ Time Frame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion ]
    The BPRS is a standardized instrument that contains scales assessing psychotic symptoms including positive and negative symptoms, activation and emotional distress.

  6. Change in Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion ]
    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.

  7. Change in Visual Analog Scale (VAS) of Mood States [ Time Frame: Baseline, 40 mins after infusion, 80 mins after infusion, 110 mins after infusion, 140 mins after infusion, 240 mins after infusion ]
    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).

  8. Time Line Follow Back (TLFB) [ Time Frame: Baseline ]
    The TLFB is a standardized measure utilized for collecting information on daily alcohol use as well as other substance use.

  9. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline ]
    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.

  10. Quality of life enjoyment and satisfaction survey (Q-LES-Q) [ Time Frame: Baseline ]
    The Q-LES-Q is a self-report measure of quality of life.

  11. Cognition [ Time Frame: 140 mins after infusion ]

    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..




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053830


Contacts
Contact: Uma Dieffenbach, BA 203-932-5711 ext 2526 uma.dieffenbach@yale.edu

Locations
United States, Connecticut
VA Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Mohini Ranganathan, MD    203-932-5711 ext 2546    mohini.ranganathan@yale.edu   
Contact: Uma Dieffenbach, BA    203-932-5711 ext 2526    uma.dieffenbach@yale.edu   
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
VA Connecticut Healthcare System

Responsible Party: Mohini Ranganathan, MD, VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT03053830     History of Changes
Other Study ID Numbers: MR0012
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mohini Ranganathan, VA Connecticut Healthcare System:
Ketamine
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder, Major
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action