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Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02593643
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Sinyor, Sunnybrook Health Sciences Centre

Brief Summary:

Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths.

Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours.

The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression.

A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression will be randomized to these two treatments.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar I Disorder Bipolar II Disorder Bipolar Depression Suicidal Ideation Drug: Ketamine Drug: Midazolam Other: Treatment as usual (TAU) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Pilot Trial of the Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: ketamine+TAU - MDD
Ketamine + treatment as usual (TAU) in MDD inpatients with SI
Drug: Ketamine
Other: Treatment as usual (TAU)
TAU includes any current treatment a patient is receiving from their primary care practitioner. In the major depressive disorder (MDD) group, TAU may include a newly initiated or longstanding antidepressant. In the bipolar depression (BD) group, TAU may include a mood stabilizer such as lithium or valproate that is a first or second line agent as per Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines (Yatham et al., 2013).

Active Comparator: midazolam + TAU - MDD
Midazolam + treatment as usual (TAU) in MDD inpatients with SI
Drug: Midazolam
Other: Treatment as usual (TAU)
TAU includes any current treatment a patient is receiving from their primary care practitioner. In the major depressive disorder (MDD) group, TAU may include a newly initiated or longstanding antidepressant. In the bipolar depression (BD) group, TAU may include a mood stabilizer such as lithium or valproate that is a first or second line agent as per Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines (Yatham et al., 2013).

Experimental: ketamine + TAU - BD
Ketamine + treatment as usual (TAU) in BD inpatients with SI
Drug: Ketamine
Other: Treatment as usual (TAU)
TAU includes any current treatment a patient is receiving from their primary care practitioner. In the major depressive disorder (MDD) group, TAU may include a newly initiated or longstanding antidepressant. In the bipolar depression (BD) group, TAU may include a mood stabilizer such as lithium or valproate that is a first or second line agent as per Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines (Yatham et al., 2013).

Active Comparator: midazolam + TAU - BD
Midazolam + treatment as usual (TAU) in BD inpatients with SI
Drug: Midazolam
Other: Treatment as usual (TAU)
TAU includes any current treatment a patient is receiving from their primary care practitioner. In the major depressive disorder (MDD) group, TAU may include a newly initiated or longstanding antidepressant. In the bipolar depression (BD) group, TAU may include a mood stabilizer such as lithium or valproate that is a first or second line agent as per Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines (Yatham et al., 2013).




Primary Outcome Measures :
  1. Montgomery-Aspberg Depression Rating Scale (MADRS) [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression of Severity/Improvement (CGI-S, CGI-I) [ Time Frame: two weeks ]
  2. Scale of Suicidal Ideation (SSI) [ Time Frame: two weeks ]
  3. Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: two weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Provision of written informed consent
  2. [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
  3. [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
  4. Both females and males, aged 18 to 65 years
  5. Inpatient status
  6. Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active
  7. The ability to understand and comply with the requirements of the study and capable of providing informed consent
  8. Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both.

Exclusion Criteria:

  1. Current or past psychotic symptoms
  2. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  3. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
  4. Any pervasive developmental disorder (according to DSM-IV criteria)
  5. Diagnosis of dementia (according to DSM-IV criteria)
  6. Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator
  7. Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician)
  8. Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam
  9. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  10. Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator
  11. Pregnancy (or female of child-bearing age not using adequate contraception) or lactation
  12. A positive β-hCG test at enrollment
  13. Involvement in the planning and conduct of the study
  14. Previous enrollment or randomisation of treatment in the present study
  15. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements

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): NCT02593643


Locations
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Canada, Ontario
Sunnybook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Publications:
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Responsible Party: Mark Sinyor, Associate Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02593643    
Other Study ID Numbers: 361-2013
First Posted: November 1, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Mark Sinyor, Sunnybrook Health Sciences Centre:
Major Depressive Disorder
Bipolar Disorder
Depression
Suicide
Suicidal Ideation
Ketamine
Midazolam
Inpatients
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Ketamine
Disease
Bipolar Disorder
Suicidal Ideation
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Suicide
Self-Injurious Behavior
Midazolam
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
Adjuvants, Anesthesia
Hypnotics and Sedatives