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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

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects
Study Start Date : July 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
All participants receive open-label ketamine
Drug: Ketamine
Intravenous ketamine 0.5mg/kg over 40 minutes
Other Name: Ketamine Hydrochloride




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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,
  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.

Information from the National Library of Medicine

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): NCT02669043


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Dawn Ionescu, M.D. MGH
  Study Documents (Full-Text)

Documents provided by Cristina Cusin, MD, Massachusetts General Hospital:
Informed Consent Form  [PDF] December 13, 2016


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Responsible Party: Cristina Cusin, MD, Assistant in Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02669043     History of Changes
Other Study ID Numbers: 2015P002397
K23MH107776 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2016    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: April 23, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Ketamine
Depression
Behavioral Symptoms
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs