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Trial record 12 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

CAP-Ketamine for Antidepressant Resistant PTSD

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ClinicalTrials.gov Identifier: NCT02655692
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : June 27, 2019
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.

Condition or disease Intervention/treatment Phase
PTSD Posttraumatic Stress Disorder Drug: Ketamine Drug: Placebo Phase 2

Detailed Description:
In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CAP-Ketamine for Antidepressant Resistant PTSD
Actual Study Start Date : April 18, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Placebo
Saline dose
Drug: Placebo
This is a saline placebo/non-active solution.

Experimental: Low Dose Ketamine
Low Dose Ketamine (.20 mg/kg)
Drug: Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.

Experimental: High Dose Ketamine
High Dose Ketamine (.50 mg/kg)
Drug: Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.




Primary Outcome Measures :
  1. PTSD Checklist to measure change in PTSD symptoms from baseline to post-treatment (4 weeks) [ Time Frame: 24-hours post-infusions; weekly for 4 weeks following last infusion ]
    The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder. Item and total scores will be recorded and aggregated from all study participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female Veterans or active duty military personnel between the ages of 18 and 70 years
  • diagnosis of PTSD
  • history of trialing one or more antidepressant medications with little to no PTSD symptom improvement
  • ability to provide written informed consent

Exclusion Criteria:

  • females who are currently pregnant or breastfeeding
  • current high risk for suicide
  • history of severe head injury

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): NCT02655692


Contacts
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Contact: Lynnette Averill Lynnette.Averill@va.gov
Contact: Selin Goktas, MS (203) 932-5711 ext 2525 selin.goktas@va.gov

Locations
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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lynnette Averill       Lynnette.Averill@va.gov   
Contact: Selin Goktas, MS    (203) 932-5711 ext 2525    selin.goktas@va.gov   
Principal Investigator: John H. Krystal, MD         
United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Bill Murff, BS    210-539-9422    murff@uthscsa.edu   
Sponsors and Collaborators
VA Office of Research and Development
The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
Investigators
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Principal Investigator: John H. Krystal, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02655692     History of Changes
Other Study ID Numbers: SPLE-003-14W
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Office of Research and Development:
PTSD
Ketamine
Veteran
Military
Clinical Trial

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Ketamine
Antidepressive Agents
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
Psychotropic Drugs