- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577250
Ketamine Infusions for PTSD and Treatment-Resistant Depression
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis Va Health Care System, Minneapolis MN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
|
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 24 hours post-infusion
|
24 hours post-infusion
|
Clinical-Administered PTSD Scale (CAPS)
Time Frame: 2 weeks after the first infusion
|
2 weeks after the first infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: up to 2 months
|
up to 2 months
|
PTSD Checklist
Time Frame: 24 hours post-infusion
|
24 hours post-infusion
|
Clinical-Administered PTSD Scale (CAPS)
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paulo Shiroma, MD, Minneapolis Veterans Affairs Medical Center
- Principal Investigator: Cristina S Albott, MD,MA, Minneapolis Veterans Affairs Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- depression
- ketamine
- analgesics
- mood disorders
- anxiety disorders
- depressive disorder
- mental disorders
- behavioral symptoms
- physiological effects of drugs
- neurotransmitter agents
- psychotropic drugs
- therapeutic uses
- pharmacologic actions
- stress disorders, post-traumatic
- stress disorders, traumatic
- adjuvants, anesthesia
- anesthetics
- anesthetics, dissociative
- anesthetics, general
- anesthetics, intravenous
- excitatory amino acid agents
- excitatory amino acid antagonists
- hypnotics and sedatives
- molecular mechanisms of pharmacological action
- peripheral nervous system agents
- sensory system agents
- central nervous system agents
- central nervous system depressants
- depressive disorder, treatment-resistant
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Trauma and Stressor Related Disorders
- Depression
- Depressive Disorder
- Disease
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Depressive Disorder, Treatment-Resistant
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 4555-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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