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Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment Resistant Depression

Intervention: Ketamine (Drug); Ketamine (Drug); Ketamine (Drug); Ketamine (Drug); Placebo Midazolam (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Maurizio Fava, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Yury Montas, Email: ymontas@partners.org


This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Clinical Details

Official title: Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hamilton Rating Scale for Depression - 6 items

Detailed description: The primary objective is to investigate whether all doses (0. 1 mg/kg, 0. 2 mg/kg, 0. 5 mg/kg, and 1. 0 mg/kg) of ketamine are superior to active placebo (midazolam 0. 045 mg/kg) therapy in the acute treatment of patients with treatment resistant depression within 72 hours (Day 3), when added to ongoing and stable antidepressant therapy.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female, 18-65 years old.

- Able to read, understand, and provide written, dated informed consent prior to


- Diagnosed with Major Depressive Disorder (MDD), single or recurrent, and currently

experiencing a Major Depressive Episode (MDE) of at least eight weeks in duration, prior to screening.

- Has a history of TRD during the current MDE.

- Meet the threshold on the total MADRS score of greater than or equal to 20 at both

screening and baseline visits (Day - 7/-28 and Day 0), as confirmed by the remote

centralized MGH CTNI rater between the screen visit and the baseline visit.

- In good general health

- For female participants, status of non-childbearing potential or use of an acceptable

form of birth control

- Body mass index between 18-35 kg/m2

- Concurrent psychotherapy will be allowed if the type and frequency of the therapy has

been stable for at least three months prior to screening and is expected to remain stable during participation in the study

- Concurrent hypnotic therapy will be allowed if the therapy has been stable for at

least 4 weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study. Exclusion Criteria:

- Female of childbearing potential who is not willing to use one of the specified forms

of birth control during the study

- Female that is pregnant or breastfeeding

- Female with a positive pregnancy test at screening or baseline

- History during the current MDE of failure to achieve a satisfactory response to >7

treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration during the current episode

- Total MADRS score of <20 at the screen or baseline visits, or as assessed by the

remote, independent MGH CTNI rater and reported to the site

- Current diagnosis of a Substance Use Disorder (Abuse or Dependence) with the

exception of nicotine dependence, at screening or within 6 months prior to screening

- Current Axis I disorder that is the principal focus of treatment and MDD the

secondary focus of treatment for the past 6 months or more

- History of bipolar disorder, schizophrenia or schizoaffective disorders, or any

history of psychotic symptoms in the current or previous depressive episodes

- History of eating disorders within five years of screening

- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their

MDD or has been predominant at any time within 6 months prior to screening

- Subject is considered at significant risk for suicidal behavior during the course of

their participation in the study

- Has failed to respond to electroconvulsive therapy during the current depressive


- Has received vagus nerve stimulation (VNS) at any time prior to screening

- Dementia, delirium, amnestic, or any other cognitive disorder

- Has a clinically significant abnormality on the screening physical examination

- Participation in any clinical trial with an investigational drug or device within the

past month or concurrent to study participation

- Known history or current episode of: hypertension, Recent myocardial infarction

(within one year) or a history of myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris, heart rate <50 or >105 beats per minute at screening or randomization, or QTcF greater than or equal to 450 msec at screening or randomization.

- Chronic lung disease

- Lifetime history of surgical procedures involving the brain or meninges,

encephalitis, meningitis, degenerative central nervous system disorder, epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past 2 years

- Presents with a history of Thyroid stimulating hormone outside of the normal limits

and clinically significant as determined by the investigator

- Patients with diabetes mellitus fulfilling any of the following criteria:

1. Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) >8. 5% at screening 2. Admitted to hospital for treatment of diabetes mellitus or diabetes mellitus related illness in the past 12 weeks 3. Not under physician care for diabetes mellitus 4. Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to screening. For thiazolidinediones (glitazones) this period should not be less than 8 weeks. 5. Any other clinically significant abnormal laboratory result (as determined after evaluation by study investigator and MGH CTNI medical monitor) at the time of the screening exam.

- History of hypothyroidism and has been on a stable dosage of thyroid replacement

medication for less than 6 months prior to screening. (Subjects on a stable dosage of thyroid replacement medication for at least 6 months or more prior to screening are eligible for enrollment.)

- History of hyperthyroidism which was treated (medically or surgically) less than six

months prior to screening

- Any current or past history of any physical condition which in the investigator's

opinion might put the subject at risk or interfere with study results interpretation

- History of positive screening urine test for drugs of abuse

- Patients with exclusionary laboratory values, or requiring treatment with

exclusionary concomitant medications

- Patients who have participated in studies of ketamine or AZD6765 for depression

- Patients with narrow angle glaucoma

- Patients with a lifetime history of PCP/Ketamine drug use

- Liver Function Tests higher than 2. 5 times upper limit of normal

Locations and Contacts

Yury Montas, Email: ymontas@partners.org

Stanford University, Palo Alto, California 94304, United States; Recruiting
Jessica Hawkins, Phone: 650-723-8323, Email: jhawk@stanford.edu
Charles DeBattista, MD, Principal Investigator

Yale University, New Haven, Connecticut 06520, United States; Recruiting
Jane Wanyiri, Phone: 203-764-9131, Email: jane.wanyiri@yale.edu
Gerard Sanacora, MD, PhD, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Mariana Cohen, Phone: 617-726-3129, Email: mcohen20@partners.org
Cristina Cusin, MD, Principal Investigator
Dawn Ionescu, MD, Sub-Investigator

Mount Sinai School of Medicine, New York, New York 10029, United States; Recruiting
Jackie Schwartz, Phone: 212-241-3116, Email: jaclyn.schwartz@mssm.edu
Dan V Iosifescu, MD, Principal Investigator

University of Texas Southwestern, Dallas, Texas 75390, United States; Recruiting
Maria Monastirsky, Phone: 214-648-0174, Email: Maria.Monastirsky@UTSouthwestern.edu
Madhukar Trivedi, MD, Principal Investigator
Marisa Toups, MD, Sub-Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Lorna Hirsch, Phone: 713-689-9856, Email: mood@bcm.edu
Sanjay J Mathew, MD, Principal Investigator

Additional Information

Starting date: December 2014
Last updated: August 18, 2015

Page last updated: August 23, 2015

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