Ketamine Infusions for PTSD and Treatment-Resistant Depression
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|ClinicalTrials.gov Identifier: NCT02577250|
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 14, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Treatment-Resistant Stress Disorders, Post-Traumatic||Drug: Ketamine||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours post-infusion ]
- Clinical-Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: up to 2 months ]
- PTSD Checklist [ Time Frame: 24 hours post-infusion ]
- Clinical-Administered PTSD Scale (CAPS) [ Time Frame: up to 2 months ]
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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|
- 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.
- 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.
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
|United States, Minnesota|
|Minneapolis Va Health Care System, Minneapolis MN|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Paulo Shiroma, MD||Minneapolis Veterans Affairs Medical Center|
|Principal Investigator:||Cristina S Albott, MD,MA||Minneapolis Veterans Affairs Medical Center|
|Responsible Party:||Cristina Sophia Albott, MD, MA, Minneapolis Veterans Affairs Medical Center|
|Other Study ID Numbers:||
|First Posted:||October 16, 2015 Key Record Dates|
|Last Update Posted:||May 14, 2019|
|Last Verified:||May 2019|
stress disorders, post-traumatic
stress disorders, traumatic
excitatory amino acid agents
excitatory amino acid antagonists
hypnotics and sedatives
molecular mechanisms of pharmacological action
peripheral nervous system agents
physiological effects of drugs
sensory system agents
central nervous system agents
central nervous system depressants
depressive disorder, treatment-resistant
Stress Disorders, Traumatic
Depressive Disorder, Treatment-Resistant
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action