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Trial record 2 of 13 for:    ketamine bipolar disorder

Ketamine for Suicidality in Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01944293
First received: September 8, 2013
Last updated: September 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Major Depressive Episode
Suicidal Ideation
Drug: Ketamine
Drug: Midazolam
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine vs. Midazolam in Bipolar Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Reduction of Suicidal Ideation measured with the Beck Scale for Suicidal Ideation [ Time Frame: At 24 hours post-Infusion ] [ Designated as safety issue: No ]
    Reduction of 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 with Ketamine or Midazolam, a sedative not known to reduce suicidal ideation.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 24 hours post-infusion ] [ Designated as safety issue: Yes ]
    Number of subjects with adverse events.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
0.5 mg/kg, I.V. (in the vein)
Drug: Ketamine
Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
Other Names:
  • Ketalar
  • Ketamine Hydrochloride Injection
Active Comparator: Midazolam
0.02 mg/kg, I.V. (in the vein)
Drug: Ketamine
Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
Other Names:
  • Ketalar
  • Ketamine Hydrochloride Injection
Drug: Midazolam
Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Other Name: Midazolam Injection

Detailed Description:

Patients currently taking psychiatric medications may continue them during the study. However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of benzodiazepine may need to be reduced so that they can do without it during the 24 hours pre-infusion.

Participants are randomly assigned to receive a single dose of ketamine (0.5 mg/kg) or Midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is "double-blind," meaning patients and study staff will not know which medication is in the infusion.

If a patient does not respond to the first infusion, and s/he received Midazolam, then s/he will be offered the option of a second infusion, this time with Ketamine (0.5 mg/kg). After the infusion(s), participants will have weekly research interviews for 6 weeks to monitor response.

After post-infusion research measures are completed, all subjects will receive open clinical treatment. During open clinical treatment, medication will be changed for those patients who don't respond or whose response is transient.

Participation in this study requires a brief inpatient stay, at no cost, at the New York State Psychiatric Institute (NYSPI).

Eligible participants enrolled in this study will be offered medication management visits at no cost for a total of up to 6 months combining inpatient and outpatient treatment. At the end of the 6 months of treatment patients will be referred for ongoing care.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 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
  • 18-65 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

EXCLUSION CRITERIA:

  • 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
  • Patients who have never received medication treatment for bipolar disorder
  • Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion
  • Diagnosis of sleep apnea
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944293

Contacts
Contact: Julia E Marver, B.A. 646-774-7627 marverj@nyspi.columbia.edu

Locations
United States, New York
Columbia University/New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Julia E Marver, B.A.    646-774-7627    marverj@nyspi.columbia.edu   
Principal Investigator: Michael F. Grunebaum, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Michael F Grunebaum, M.D. Columbia Unviversity/New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01944293     History of Changes
Other Study ID Numbers: #6785
Study First Received: September 8, 2013
Last Updated: September 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Ketamine
Midazolam
Bipolar Disorder
Major Depressive Episode
Suicidal Ideation
Suicide
Depression
Treatment
Ketamine Treatment

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Ketamine
Depression
Suicidal Ideation
Behavioral Symptoms
Self-Injurious Behavior
Suicide
Midazolam
Adjuvants, Anesthesia
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014