Ketamine for Suicidality in Bipolar Depression

NCT01944293 | Completed Phase 1 Results DMC

• 1 other identifier: #6785
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression. The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.

Conditions

Bipolar Disorder; Major Depressive Episode; Suicidal Ideation

Keywords

Ketamine; Midazolam; Bipolar Disorder; Major Depressive Episode; Suicidal Ideation; Suicide; Depression; Treatment; Ketamine Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation

  Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).

  At 24 hours post-Infusion

Secondary Outcomes (1)

• Change in Systolic Blood Pressure

  During study infusion

Study Arms (2)

Ketamine

EXPERIMENTAL

0.5 mg/kg, I.V. (in the vein)

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

0.02 mg/kg, I.V. (in the vein)

Drug: Midazolam

Interventions

Ketamine DRUG

Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Also known as: Ketalar, Ketamine Hydrochloride Injection

Ketamine

Midazolam DRUG

Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes

Also known as: Midazolam Injection

Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.
• Moderate to severe suicidal ideation
• years old
• Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
• Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills
• Able to provide informed consent
• Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening

You may not qualify if:

• Unstable medical condition or neurological illness, including baseline hypertension (BP\>140/90) or significant history of cardiovascular illness
• Significant ECG abnormality
• Pregnancy and/or lactation
• Current psychotic symptoms
• Contraindication to any study treatment
• Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
• Inadequate understanding of English
• Prior ineffective trial of or adverse reaction to ketamine or midazolam
• Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• MIND Clinic for Mood and Personality Disorders

MeSH Terms

Conditions

Bipolar Disorder; Suicidal Ideation; Suicide; Depression

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Grunebaum, MD
• Organization: Columbia University Medical Center - NY State Psychiatric Institute

michael.grunebaum@nyspi.columbia.edu

646-774-7573

Study Officials

• Michael F Grunebaum, M.D.

  Columbia Unviversity/New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Study Record Dates

• First Submitted: September 8, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2018
• Last Updated: March 11, 2020
• Results First Posted: June 6, 2019

Record last verified: 2020-02

Locations

US (1)