Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients

NCT02106325 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 13-00794
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment for people with Major Depressive Disorder. This study plans to explore the potential that Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to the Emergency Department with severe depression. Since this is a controlled trial we will use an IV of Ketamine or and equivalent volume of Diphenhydramine. Subjects will be randomly assigned to receive Ketamine or Benadryl. Investigators will then compare measures of mood pre- and post-infusion in the Emergency Department. To supplement self-reported measures of depressive symptoms(e.g. mood), investigators will obtain objective measures of the biological aspects of Major Depressive Disorder.

Conditions

Depression

Keywords

Ketamine; Ketlar; Depression; Antidepressants; Treatment; Acute

Outcome Measures

Primary Outcomes (3)

• Evaluate the Effects of Ketamine on Depressive Symptomatology by Measuring Change in Score on the Montgomery-Asberg Depressive Rating Scale

  40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points. 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

  Baseline and 16 weeks

• Beck Depression Inventory-II (BDI-II)

  BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. 0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression

  120 min post-infusion

• Hamilton Depression Scale (Ham-D)

  Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Sum the scores from the first 17 items 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression \>23= Very Severe Depression

  4-6 hours post-infusion

Secondary Outcomes (6)

• Change in Treatment Alliance Score

  Baseline and 16 weeks

• Beck Scale for Suicidal Ideation (BSSI)

  40 minutes post-infusion

• Montgomery-Åsberg Depression Rating Scale Suicide Ideation Item (MADRS-SI)

  40 minutes post-infusion

• Length of Inpatient Stay

  2 Weeks Post-infusion

• Outpatient Follow-up Compliance

  1 Day

Study Arms (2)

Ketamine

EXPERIMENTAL

IV Ketamine .25mg/kg

Drug: Ketamine

Diphenhydramine

PLACEBO COMPARATOR

25mg Diphenhydramine

Drug: Diphenhydramine

Interventions

Ketamine DRUG

IV of Ketamine (.25mg/kg)

Also known as: Other names for ketamine: ketalar

Ketamine

Diphenhydramine DRUG

Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department

Also known as: Other names for diphenhydramine: benadryl

Diphenhydramine

Eligibility Criteria

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

You may qualify if:

• Medically stable as determined by the medical physician
• Meets criteria for Major Depressive Disorder (MDD) based on a structured clinical Interview (MINI International Neuropsychiatric Interview).
• Reports symptoms of severe depression at the time of presentation, defined as a score of 24 or greater on the MADRS.
• Patients for whom a psychiatric evaluation and disposition decision has been made by emergency psychiatry staff to admit to an inpatient psychiatric unit at Bellevue Hospital Center or NYU Tisch Hospital.
• Each subject must have a level of understanding sufficient to sign an informed consent stating that the treatment being offered is not FDA approved for the treatment of depression and is being provided as an off-label option.

You may not qualify if:

• Pregnancy
• Inability to read or understand English
• Current clinical signs of intoxication or delirium at time of study intervention
• Overdose, within previous 24 hours, of any agent which would impair ketamine metabolism
• Lifetime misuse/abuse of ketamine, phencyclidine (PCP),or related substances
• Lifetime history of psychotic spectrum illness
• First-degree relative with history of psychotic illness
• Lifetime diagnosis of borderline personality disorder, or as confirmed by assessment using items #90-104 of the SCID-II (for DSM-IV).
• Subjects with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), O2 saturation measure, 12-lead ECG, clinical laboratory tests (CBC, chemistry panel, thyroid function tests), urine drug screen, and urine pregnancy test (for females of childbearing potential only).
• Clinically unstable medical, surgical or neurological conditions at ED presentation
• History of stroke or intracranial hypertension
• History of glaucoma
• Subjects with one or more seizures without a clear and resolved etiology
• Current NMDA antagonist medications (eg. Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)
• Known hypersensitivity to ketamine or amantadine

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

NYU Langone Medical Center/Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine; Diphenhydramine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Stephen Ross, MD/ Principal Investigator
• Organization: New York University School of Medicine

Stephen.Ross@nyumc.org

212 562 4097

Study Officials

• Stephen Ross, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• K. Casey Paleos, MD

  New York Unversity School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: April 8, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 14, 2018
• Results First Posted: September 14, 2018

Record last verified: 2018-08

Locations

US (2)