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Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects

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ClinicalTrials.gov Identifier: NCT02669043
Recruitment Status : Terminated (Funding ended.)
First Posted : January 29, 2016
Results First Posted : February 28, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE January 29, 2016
Results First Submitted Date  ICMJE February 24, 2017
Results First Posted Date  ICMJE February 28, 2017
Last Update Posted Date April 23, 2018
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
Hamilton Depression Rating Scale (HDRS, HAM-D) [ Time Frame: 48 hours ]
Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Hamilton Depression Rating Scale (HDRS, HAM-D) [ Time Frame: 48 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Hamilton Anxiety Rating Scale [ Time Frame: 48 hours ]
  • Young Mania Rating Scale [ Time Frame: 48 hours ]
  • CUDOS-A [ Time Frame: 48 hours ]
  • SHAPS [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
Official Title  ICMJE Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
Brief Summary Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of depression within hours in many patients with "treatment-resistant" depression, has been associated with superior efficacy in those individuals with anxious compared with non-anxious depression. In order to understand this unique effect more fully, the current protocol is aimed at further delineating biomarkers of ketamine's effects among individuals with treatment-resistant anxious depression compared to those with nonanxious depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Depression
Intervention  ICMJE Drug: Ketamine
Intravenous ketamine 0.5mg/kg over 40 minutes
Other Name: Ketamine Hydrochloride
Study Arms  ICMJE Experimental: Ketamine
All participants receive open-label ketamine
Intervention: Drug: Ketamine
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 27, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
70
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. be 18-64 years old,
  2. read, understand, and provide written informed consent in English,
  3. meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) for ≥ 4 weeks,
  4. have a history ≥1 failed medication trial during the current depression,
  5. be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,
  6. maintain a treating doctor who is in agreement with study participation,
  7. have a reliable chaperone to accompany them home following the completion of the ketamine infusion day,
  8. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
  9. be of non-childbearing potential or use of an acceptable form of birth control (females only).

Exclusion Criteria:

  1. delirium or dementia diagnosis,
  2. unstable medical illness or clinically significant laboratory results,
  3. history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure >140/95 mmHg at Screening,
  4. history of multiple adverse drug reactions,
  5. current/past history of psychotic disorders, history of out-of-body feelings or derealization,
  6. active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP (phencyclidine) abuse (we will confirm this with collateral information from their doctor if necessary),
  7. requirement of excluded medications that may interact with ketamine,
  8. caffeine or nicotine use within 1 hour of psychophysiology testing, or alcohol use within 1 day of testing,
  9. pregnancy, breastfeeding, or unacceptable means of birth control (females only)
  10. clinically significant hearing impairment,
  11. current serious suicidal or homicidal risk,
  12. concurrent participation in other research studies involving medications or other treatments,
  13. narrow angle glaucoma,
  14. acute intermittent porphyria history,
  15. history of seizures in the past 6 months, regardless of seizure type,
  16. hyperthyroidism or untreated hypothyroidism,
  17. airway instability or pulmonary disease with hypercarbia, or
  18. current or past cubital or carpal tunnel syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02669043
Other Study ID Numbers  ICMJE 2015P002397
K23MH107776 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Original Responsible Party Dawn F Ionescu, Massachusetts General Hospital, Assistant in Psychiatry
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Dawn Ionescu, M.D. MGH
PRS Account Massachusetts General Hospital
Verification Date March 2018

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