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History of Changes for Study: NCT02669043
Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
Latest version (submitted March 22, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 27, 2016 None (earliest Version on record)
2 January 29, 2016 Outcome Measures and Study Status
3 March 21, 2016 Outcome Measures, Arms and Interventions and Study Status
4 August 8, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 September 7, 2016 Study Status, Eligibility, Outcome Measures and Study Description
6 February 24, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design, Outcome Measures, Study Identification, Results, Eligibility and Arms and Interventions
7 February 27, 2017 Study Design and Study Status
8 July 18, 2017 More Information, Study Status, Document Section and Sponsor/Collaborators
9 March 22, 2018 Document Section and Study Status
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Study NCT02669043
Submitted Date:  January 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2015P002397
Brief Title: Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2016
Overall Status: Not yet recruiting
Study Start: April 2016
Primary Completion: March 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: January 27, 2016
First Submitted that
Met QC Criteria:
January 27, 2016
First Posted: January 29, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 27, 2016
Last Update Posted: January 29, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party: Principal Investigator
Investigator: Dawn F Ionescu
Official Title: Assistant in Psychiatry
Affiliation: Massachusetts General Hospital
Collaborators: National Institute of Mental Health (NIMH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Depression
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 70 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Drug: Ketamine
Intravenous ketamine 0.5mg/kg over 40 minutes
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Hamilton Depression Rating Scale (HDRS, HAM-D)
[ Time Frame: 48 hours ]

Secondary Outcome Measures:
1. Hamilton Anxiety Rating Scale
[ Time Frame: 48 hours ]

2. Young Mania Rating Scale
[ Time Frame: 48 hours ]

3. CUDOS-A
[ Time Frame: 48 hours ]

4. SHAPS
[ Time Frame: 48 hours ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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, according to the Mini International Neuropsychiatric Interview (M.I.N.I.) and have a Hamilton Depression Rating Scale (HDRS-28) total score ≥ 20; depression may have started at any time point in their life, and certain co-morbid diagnoses (e.g., anxiety disorders) will be allowed,
  4. have a history ≥1 failed medication trial during the current depressive episode (per the MGH Antidepressant Treatment History Questionnaire),
  5. be on a stable adequate dose of the antidepressant citalopram for ≥14 days prior to Study Phase II,
  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 Visit 3 (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 or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed), BP >180/110 mmHg
  4. history of multiple adverse drug reactions, (e.g., history of hives or anaphylaxis in response to a medication, severe intolerance and/or severe side effects to a medication), including hypersensitivity to ketamine,
  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 abuse (we will confirm this with collateral information from their doctor),
  7. requirement of excluded medications that may interact with ketamine (see exclusionary medications list),
  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,
  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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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