Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects

NCT02669043 | Terminated Results DMC

• 2 other identifiers: 2015P002397K23MH107776
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with anxious depression do not respond as well to currently available antidepressant medications. Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of depression within hours in many patients with "treatment-resistant" depression, has been associated with superior efficacy in those individuals with anxious compared with non-anxious depression. In order to understand this unique effect more fully, the current protocol is aimed at further delineating biomarkers of ketamine's effects among individuals with treatment-resistant anxious depression compared to those with nonanxious depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS, HAM-D)

  Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.

  48 hours

Study Arms (1)

Ketamine

EXPERIMENTAL

All participants receive open-label ketamine

Drug: Ketamine

Interventions

Ketamine DRUG

Intravenous ketamine 0.5mg/kg over 40 minutes

Also known as: Ketamine Hydrochloride

Ketamine

Eligibility Criteria

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

You may qualify if:

• be 18-64 years old,
• read, understand, and provide written informed consent in English,
• meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) for ≥ 4 weeks,
• have a history ≥1 failed medication trial during the current depression,
• be on a stable adequate dose of an FDA-approved antidepressant medication for ≥28 days,
• maintain a treating doctor who is in agreement with study participation,
• have a reliable chaperone to accompany them home following the completion of the ketamine infusion day,
• be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
• be of non-childbearing potential or use of an acceptable form of birth control (females only).

You may not qualify if:

• delirium or dementia diagnosis,
• unstable medical illness or clinically significant laboratory results,
• history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects (e.g., requirement of cardiac pacemaker) or alter brain morphology (e.g., recent head trauma, post intracranial surgery, intracranial mass or bleed or unstable sleep apnea), or a blood pressure \>140/95 mmHg at Screening,
• history of multiple adverse drug reactions,
• current/past history of psychotic disorders, history of out-of-body feelings or derealization,
• active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP (phencyclidine) abuse (we will confirm this with collateral information from their doctor if necessary),
• requirement of excluded medications that may interact with ketamine,
• caffeine or nicotine use within 1 hour of psychophysiology testing, or alcohol use within 1 day of testing,
• pregnancy, breastfeeding, or unacceptable means of birth control (females only)
• clinically significant hearing impairment,
• current serious suicidal or homicidal risk,
• concurrent participation in other research studies involving medications or other treatments,
• narrow angle glaucoma,
• acute intermittent porphyria history,
• history of seizures in the past 6 months, regardless of seizure type,

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr.Cristina Cusin
• Organization: Massachusetts General Hospital

ccusin@partners.org

617-726-6421

Study Officials

• Dawn Ionescu, M.D.

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychiatry

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 23, 2018
• Results First Posted: February 28, 2017

Record last verified: 2018-03

Locations

US (1)