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OpenTrials
Completed

NCT Number: NCT03053830

Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Healthcare System

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ketamine

Drug

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

Primary outcomes

  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..

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Official study title

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

Acronym: Ket-MDD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2017
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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