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

Completed · Phase 2 · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT01920555

Run by

Massachusetts General Hospital

People needed

99

Starts

2014-12-01

Expected to finish

2017-02-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18-70 years old.
• Able to read, understand, and provide written, dated informed consent prior to screening.
• 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.

You may not qualify if…

• 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 (ECT) during the current depressive episode
• Has received vagus nerve stimulation (VNS) at any time prior to screening
• Has 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
• Current episode of:
• Hypertension, Stage 1 as defined by a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements (standing and supine) at least 15 minutes apart.
• Hypertension, Stage 1 as defined by a systolic blood pressure ≥155 mmHg or diastolic blood pressure ≥99 mmHg at the Baseline Visit (Visit 1) within 1.5 hours prior to randomization on two of three measurements (standing and supine) at least 15 minutes apart.
• Recent myocardial infarction (within one year) or a history of myocardial infarction.
• Syncopal event within the past year.
• Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
• Angina pectoris.
• Heart rate <50 or >105 beats per minute at screening or randomization (Baseline Visit).
• QTcF (Fridericia-corrected) ≥450 msec at screening or randomization (Baseline Visit).

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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