Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

NCT03053830 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MR0012
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Ketamine; Major Depressive Disorder

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Quality of life enjoyment and satisfaction survey (Q-LES-Q)

  The Q-LES-Q is a self-report measure of quality of life.

  Baseline

• 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Ketamine DRUG

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

Intervention Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (1)

VA Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 15, 2017
• Study Start: January 31, 2017
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)