Ketamine Infusion Therapy for PTSD in Combat Veterans

NCT03088384 | Completed DMC FDA Drug

• 1 other identifier: KRP001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Post Traumatic Stress Disorder; PTSD; Combat Trauma

Outcome Measures

Primary Outcomes (1)

• Participant score on the PTSD Checklist - 5 (PCL-5) after a series of six ketamine infusions.

  The PCL-5 is a twenty question survey instrument which is used to quantify the level of symptomatology in participants with post-traumatic stress disorder.

  3 weeks

Secondary Outcomes (3)

• Participant score on the Patient Health Questionnaire - 9 (PHQ-9) after a series of six ketamine infusions.

  3 weeks

• Participant score on the Drug Abuse Screening Test (DAST-10) after a series of six ketamine infusions.

  3 weeks

• Participant score on the Alcohol Use Disorders Identification Test (AUDIT) after a series of six ketamine infusions.

  3 weeks

Study Arms (1)

Combat Veterans

Eligible participants must be military veterans who have served in a combat zone as evidenced by documentation on the subject's DD214 (or equivalent if he/she served in a foreign military). Participants must have a diagnosis of post traumatic stress disorder that was as a result of their military combat experience.

Drug: Ketamine

Interventions

Ketamine DRUG

Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.

Combat Veterans

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans of the United States or foreign militaries who have served in combat and who now suffer from post traumatic stress disorder as a result of that military service.

You may qualify if:

• The Veteran must be medically screened by Klarisana and be an appropriate candidate for ketamine therapy
• The Veteran must be between the ages of 18 and 75. The study is open to men and women.
• The Veteran must be able to speak and read the English language
• The Veteran must have a diagnosis of post-traumatic stress disorder assigned by the Department of Veterans Affairs. Veterans of a foreign military are also eligible but they must have been diagnosed with PTSD by the equivalent veteran healthcare organization in their country of military service
• The Veteran must have served in the US Military or a foreign military service in a designated combat zone. Documentation by a DD214 or equivalent is required
• The PTSD that The Veteran is suffering from has to have been caused by service in combat
• The PTSD that the Veteran is suffering from must be exerting a significant negative effect on his/her life

You may not qualify if:

• The Veteran must NOT be taking lamotrigine (Lamictal) or any monoamine oxidase inhibitor antidepressants
• The Veteran must not be currently enrolled in any other studies offering therapy for PTSD
• Veteran may NOT have uncontrolled blood pressure or congestive heart failure
• Veteran may NOT have a diagnosis of psychosis or any diagnosis on the psychosis spectrum

Sponsors & Collaborators

• Klarisana Physician Services PLLC: lead

Study Sites (1)

Klarisana

San Antonio, Texas, 78240, United States

Location

Related Publications (8)

• Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.

  PMID: 24740528 BACKGROUND

• Murrough JW, Soleimani L, DeWilde KE, Collins KA, Lapidus KA, Iacoviello BM, Lener M, Kautz M, Kim J, Stern JB, Price RB, Perez AM, Brallier JW, Rodriguez GJ, Goodman WK, Iosifescu DV, Charney DS. Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial. Psychol Med. 2015 Dec;45(16):3571-80. doi: 10.1017/S0033291715001506. Epub 2015 Aug 12.

  PMID: 26266877 BACKGROUND

• McGowan JC, LaGamma CT, Lim SC, Tsitsiklis M, Neria Y, Brachman RA, Denny CA. Prophylactic Ketamine Attenuates Learned Fear. Neuropsychopharmacology. 2017 Jul;42(8):1577-1589. doi: 10.1038/npp.2017.19. Epub 2017 Jan 27.

  PMID: 28128336 BACKGROUND

• Brachman RA, McGowan JC, Perusini JN, Lim SC, Pham TH, Faye C, Gardier AM, Mendez-David I, David DJ, Hen R, Denny CA. Ketamine as a Prophylactic Against Stress-Induced Depressive-like Behavior. Biol Psychiatry. 2016 May 1;79(9):776-786. doi: 10.1016/j.biopsych.2015.04.022. Epub 2015 May 4.

  PMID: 26037911 BACKGROUND

• Burbiel JC. Primary prevention of posttraumatic stress disorder: drugs and implications. Mil Med Res. 2015 Oct 26;2:24. doi: 10.1186/s40779-015-0053-2. eCollection 2015.

  PMID: 26504586 BACKGROUND

• Fortea A, Espinosa L, Oliveras C, Bruguera P, Benabarre A. Ketamine associated with electroconvulsive therapy for treatment-resistant depression in the elderly: Two case reports. Rev Psiquiatr Salud Ment. 2017 Apr-Jun;10(2):125-126. doi: 10.1016/j.rpsm.2016.12.001. Epub 2017 Feb 10. No abstract available. English, Spanish.

  PMID: 28209259 BACKGROUND

• Witkin JM, Mitchell SN, Wafford KA, Carter G, Gilmour G, Li J, Eastwood BJ, Overshiner C, Li X, Rorick-Kehn L, Rasmussen K, Anderson WH, Nikolayev A, Tolstikov VV, Kuo MS, Catlow JT, Li R, Smith SC, Mitch CH, Ornstein PL, Swanson S, Monn JA. Comparative Effects of LY3020371, a Potent and Selective Metabotropic Glutamate (mGlu) 2/3 Receptor Antagonist, and Ketamine, a Noncompetitive N-Methyl-d-Aspartate Receptor Antagonist in Rodents: Evidence Supporting the Use of mGlu2/3 Antagonists, for the Treatment of Depression. J Pharmacol Exp Ther. 2017 Apr;361(1):68-86. doi: 10.1124/jpet.116.238121. Epub 2017 Jan 30.

  PMID: 28138040 BACKGROUND

• Murrough JW, Burdick KE, Levitch CF, Perez AM, Brallier JW, Chang LC, Foulkes A, Charney DS, Mathew SJ, Iosifescu DV. Neurocognitive effects of ketamine and association with antidepressant response in individuals with treatment-resistant depression: a randomized controlled trial. Neuropsychopharmacology. 2015 Mar 13;40(5):1084-90. doi: 10.1038/npp.2014.298.

  PMID: 25374095 BACKGROUND

Related Links

• For more information on the study sponsor - Klarisana

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 23, 2017
• Study Start: November 28, 2016
• Primary Completion: September 27, 2018
• Study Completion: September 29, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)