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Ketamine Infusions for PTSD and Treatment-Resistant Depression

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577250
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center

Study Description
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Brief Summary:
The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Stress Disorders, Post-Traumatic Drug: Ketamine Phase 1

Detailed Description:

The proposed study is a pilot study designed to determine the efficacy and safety of serial ketamine infusions among veterans with treatment-resistant depression (TRD) as well as chronic post-traumatic stress disorder (PTSD). The investigators hypothesize that six infusions of ketamine will be effective in decreasing severity of depressive symptoms and maintaining response.

Participants will be male/female veterans (18 to 75 years old) of any era or military background who suffer from TRD and chronic PTSD. Potential participants will be recruited from Mental Health clinics and screened for eligibility using a two stage process (phone/chart review, followed by interview). Participants will receive six ketamine infusions on a Monday-Wednesday-Friday schedule over 2 weeks. On the day of infusion, participants will be required to stay at the clinical site for 3 hours after the medication has been given. Follow-up visits will occur at different time points over the course of 2 months after the two week infusion period has been completed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Repeated Intravenous Subanesthetic Ketamine Infusions Among Veterans With Treatment Resistant Depression Comorbid With Chronic Post-Traumatic Stress Disorder: A Proof-of-concept Study
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
 Drug: Ketamine
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours post-infusion ]
  2. Clinical-Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]

Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: up to 2 months ]
  2. PTSD Checklist [ Time Frame: 24 hours post-infusion ]
  3. Clinical-Administered PTSD Scale (CAPS) [ Time Frame: up to 2 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female veterans aged 18 to 75 years.
  • Participants must have a telephone in their home and ability to hear telephone conversations.
  • Participants must meet current DSM-IV criteria for major depressive disorder (MDD), single or recurrent, without psychotic features
  • Participants must meet DSM-5 criteria for current post-traumatic stress disorder (PTSD) and have received a diagnosis of PTSD greater than or equal to 3 months prior to assessment.
  • Current major depressive episode resistant to treatment.
  • If applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.

Exclusion Criteria:

  • Inability to speak English
  • Inability or unwillingness to provide written informed consent
  • Moderate/severe cognitive impairment .
  • Current or lifetime diagnosis of psychosis-related disorder, bipolar I or II disorder, substance-induced mood disorder, or any mood disorder due to a general medical condition.
  • Current or lifetime diagnosis of a Cluster B disorder.
  • History of moderate or severe traumatic brain injury, Parkinson's disease, dementia of any type, multiple sclerosis, seizures or other CNS related disorders.
  • History of comorbid substance disorder within 6 months of screening as assessed using the Mini International Neuropsychiatric Interview (MINI), plus positive urine toxicology screen test during baseline assessments.
  • Prior use of ketamine as an antidepressant.
  • Clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension)
  • Current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (MAOI).
  • History of antidepressant- or substance-induced hypomania.
  • History of first degree relative(s) with an Axis I psychotic disorder.
  • For women: pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study.
  • Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.
Contacts and Locations
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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): NCT02577250


Locations
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United States, Minnesota
Minneapolis Va Health Care System, Minneapolis MN
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
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Principal Investigator: Paulo Shiroma, MD Minneapolis Veterans Affairs Medical Center
Principal Investigator: Cristina S Albott, MD,MA Minneapolis Veterans Affairs Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cristina Sophia Albott, MD, MA, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02577250    
Other Study ID Numbers: 4555-B
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center:
ketamine
stress disorders, post-traumatic
stress disorders, traumatic
anxiety disorders
mental disorders
adjuvants, anesthesia
analgesics
anesthetics
anesthetics, dissociative
anesthetics, general
anesthetics, intravenous
excitatory amino acid agents
excitatory amino acid antagonists
hypnotics and sedatives
molecular mechanisms of pharmacological action
 neurotransmitter agents
peripheral nervous system agents
pharmacologic actions
physiological effects of drugs
psychotropic drugs
sensory system agents
central nervous system agents
central nervous system depressants
depression
depressive disorder
depressive disorder, treatment-resistant
behavioral symptoms
mood disorders
therapeutic uses
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Stress Disorders, Traumatic
Depressive Disorder, Treatment-Resistant
Stress Disorders, Post-Traumatic
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders
Ketamine
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