Ketamine Infusions for PTSD and Treatment-Resistant Depression

NCT02577250 | Completed Phase 1 DMC

• 1 other identifier: 4555-B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Treatment-Resistant; Stress Disorders, Post-Traumatic

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  24 hours post-infusion

• Clinical-Administered PTSD Scale (CAPS)

  2 weeks after the first infusion

Secondary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  up to 2 months

• PTSD Checklist

  24 hours post-infusion

• Clinical-Administered PTSD Scale (CAPS)

  up to 2 months

Study Arms (1)

Six ketamine infusions

EXPERIMENTAL

Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.

Drug: Ketamine

Interventions

Ketamine DRUG

Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.

Six ketamine infusions

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis Va Health Care System, Minneapolis MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• Albott CS, Lim KO, Forbes MK, Erbes C, Tye SJ, Grabowski JG, Thuras P, Batres-Y-Carr TM, Wels J, Shiroma PR. Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant Depression. J Clin Psychiatry. 2018 May/Jun;79(3):17m11634. doi: 10.4088/JCP.17m11634.

  PMID: 29727073 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Anxiety Disorders; Mental Disorders; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Paulo Shiroma, MD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Cristina S Albott, MD,MA

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MA

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 16, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

US (1)