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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Ketamine; Midazolam

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