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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
0.5mg/kg ketamine in normal saline. Infusion will be delivered during a 40 minute interval
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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..
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
|Contact: Uma Dieffenbach, BA||203-932-5711 ext firstname.lastname@example.org|
|United States, Connecticut|
|VA Healthcare System||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Mohini Ranganathan, MD 203-932-5711 ext 2546 email@example.com|
|Contact: Uma Dieffenbach, BA 203-932-5711 ext 2526 firstname.lastname@example.org|
|Principal Investigator: Mohini Ranganathan, MD|