Double-Blind, Placebo-Controlled Trial of... — Clinical Trial Details

Participants

Ages

18 – 70

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Inclusion Criteria

Inclusion Criteria:
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.

Exclusion Criteria

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 (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:
1. 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.
2. 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.
3. Recent myocardial infarction (within one year) or a history of myocardial infarction.
4. Syncopal event within the past year.
5. Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
6. Angina pectoris.
7. Heart rate <50 or >105 beats per minute at screening or randomization (Baseline Visit).
8. QTcF (Fridericia-corrected) ≥450 msec at screening or randomization (Baseline Visit).

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Efficacy of intravenous ketamine treatment in anxious versus nonanxious unipolar treatment-resistant depression

Integration

Study Arms & Interventions

Ketamine 0.1 mg/kg

Interventions

Ketamine 0.2 mg/kg

Interventions

Ketamine 0.5 mg/kg

Interventions

Ketamine 1.0 mg/kg

Interventions

Midazolam 0.045 mg/kg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators

Repeat-dose ketamine augmentation for treatment-resistant depression with chronic suicidal ideation: A randomized, double blind, placebo controlled trial

The effect of single administration of intravenous ketamine augmentation on suicidal ideation in treatment-resistant unipolar depression: Results from a randomized double-blind study

Factors Associated with Antidepressant Effects of Ketamine: A Reanalysis of Double-Blind Randomized Placebo-Controlled Trial of Intravenous Ketamine for Treatment-Resistant Depression