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Trial record 16 of 852 for:    Ketamine

Ketamine for Depression and Suicide Risk (Ketamine)

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ClinicalTrials.gov Identifier: NCT02094898
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
William V. Bobo, M.D., Mayo Clinic

Brief Summary:
The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.

Condition or disease Intervention/treatment Phase
Depression Suicide Drug: Ketamine Phase 2

Detailed Description:
This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine infusion
This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.
Drug: Ketamine
0.3 mg/kg/hr of ketamine infused for 100 minutes
Other Name: Ketalar




Primary Outcome Measures :
  1. MADRS Total Score at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.


Secondary Outcome Measures :
  1. MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.

  2. MADRS Factor 1 Score at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

  3. MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

  4. MADRS Factor 2 Score at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

  5. MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

  6. MADRS Factor 3 Score at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

  7. MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

  8. MADRS Factor 4 Score at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

  9. MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

  10. MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)

  11. MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)

  12. Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).

  13. CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation [ Time Frame: baseline, last acute phase observation (approximately 2 weeks) ]
    The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
  • Ability to provide informed consent
  • Male/Female
  • Age 18-65 yrs.
  • Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment
  • Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks
  • Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R) or score of ≥1on Item 9 of PHQ-9 (all at admission assessment)
  • Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria
  • Voluntary admission

Exclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
  • Index episode of depression greater than 2 years
  • Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
  • Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
  • Any active or unstable medical condition as judged by principal investigator
  • Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months
  • Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, < 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.
  • History of traumatic brain injury
  • Developmental delay and intellectual disorder
  • Encephalopathy (clinical diagnosis within prior 12 months of delirium)
  • Cognitive disorder (mild and major)
  • Previous participation in earlier Ketamine trial
  • Pregnancy
  • Prisoners
  • Involuntarily hospitalized

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): NCT02094898


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: William V Bobo, MD Consultant - Psychiatry

Publications of Results:
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Responsible Party: William V. Bobo, M.D., Consultant - Psychiatry, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02094898     History of Changes
Other Study ID Numbers: 13-005152
First Posted: March 24, 2014    Key Record Dates
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William V. Bobo, M.D., Mayo Clinic:
Depression
Unipolar
Bipolar
Suicidal
Additional relevant MeSH terms:
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Ketamine
Depression
Depressive Disorder
Suicide
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior
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