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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
Sponsor:
Information provided by (Responsible Party):
Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE October 9, 2015
First Posted Date  ICMJE October 16, 2015
Last Update Posted Date May 14, 2019
Study Start Date  ICMJE May 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusions for PTSD and Treatment-Resistant Depression
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder, Treatment-Resistant
  • Stress Disorders, Post-Traumatic
Intervention  ICMJE Drug: Ketamine
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
Study Arms  ICMJE Experimental: Six ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
Intervention: Drug: Ketamine
Publications * 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). pii: 17m11634. doi: 10.4088/JCP.17m11634.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 14, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02577250
Other Study ID Numbers  ICMJE 4555-B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paulo Shiroma, MD Minneapolis Veterans Affairs Medical Center
Principal Investigator: Cristina S Albott, MD,MA Minneapolis Veterans Affairs Medical Center
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP