Intranasal Ketamine in Treatment-Resistant Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: placebo; Drug: Ketamine

• Registration Number: NCT01304147
• Lead Sponsor: James Murrough

Brief Summary

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Study Start: 2011-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-04-18
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-16
• Last Update Submitted: 2016-12-16
• Results First Posted: 2017-02-08
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female patients, 21-65 years;
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
4. Current depressive episode;
5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
7. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
8. Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria

1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Drug or alcohol abuse or dependence within the preceding 6 months;
6. Lifetime abuse or dependence on ketamine or phencyclidine;
7. Patients judged by study investigator to be at high risk for suicide.
8. Previous participation in a ketamine study at Mount Sinai

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Subjects randomized to this arm will receive intranasal saline.
Ketamine	Ketamine	Subjects randomized to this arm will receive the active study medication, intranasal ketamine.

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	24 hours	Number of patients meeting response criteria of \>=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration; 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.

Secondary Outcome Measures

Name	Time	Method
Systematic Assessment for Treatment Emergent Effects (SAFTEE)	2 weeks	This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York City, New York, United States