Intranasal Ketamine in Treatment-Resistant Depression

Major Depressive Disorder Clinical Trial

Official title:

Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304147
• Other study ID #: GCO 11-0492
• Secondary ID: INKET-001
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: November 17, 2014
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Drug:
• Ketamine
A single dose of intranasal ketamine up to 50 mg
• placebo
Single dose of saline intranasal

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
James Murrough

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	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.	24 hours	No
Secondary	Systematic Assessment for Treatment Emergent Effects (SAFTEE)	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.	2 weeks	Yes

External Links

•   Mount Sinai School of Medicine Mood and Anxiety Disorders Program