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Trial record 16 of 851 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

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE March 24, 2014
Results First Submitted Date  ICMJE May 3, 2017
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date August 11, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Improvement in depressive symptoms [ Time Frame: Measured at baseline, with each treatment (up to 3 times weekly) acutely, and then weekly with maintenance treatment (4 weeks), then once weekly with follow up after treatment ends for four weeks. ]
The primary outcome will be remission as defined by a Montgomery Asberg Depression Scale (MADRS) score </=9
Change History Complete list of historical versions of study NCT02094898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.)
  • 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.)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Reduction of suicide risk [ Time Frame: Measured at baseline, with each treatment (up to 3 times weekly) acutely, and then weekly with maintenance treatment (4 weeks), then once weekly with follow up after treatment ends for four weeks. ]
The secondary outcome measures include reduction of suicidality as defined by a reduction in the Suicide Status Form (SSF II-R) score and suicide assessment of MADRS along wit self-report remission of symptoms as defined by a Quick Inventory of Depressive Symptomatology Self-Report of </=5.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Depression and Suicide Risk
Official Title  ICMJE Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicide
Intervention  ICMJE Drug: Ketamine
0.3 mg/kg/hr of ketamine infused for 100 minutes
Other Name: Ketalar
Study Arms  ICMJE 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.
Intervention: Drug: Ketamine
Publications * Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12. Erratum in: J Affect Disord. 2018 Aug 15;236:313.

*   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
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2014)
30
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT02094898
Other Study ID Numbers  ICMJE 13-005152
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party William V. Bobo, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William V Bobo, MD Consultant - Psychiatry
PRS Account Mayo Clinic
Verification Date August 2017

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