Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582945
• Other study ID #: 2010-P-002800
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: April 18, 2017
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).

This is an open-label study (pilot).

Description:

Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

Total duration of the study is 5 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Outpatients with severe treatment-resistant MDD

• Currently depressed

• Currently under regular psychiatric care

• On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

• No history of other major psychiatric illnesses, including bipolar disorder

• No history of psychosis

• No history of drug abuse

• No major medical illness or unstable medical conditions

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Suicidal Ideation

Intervention

Drug:
• Ketamine
Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Locations

Country	Name	City	State
United States	Depression Clinical and Research Program - MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cusin C, Ionescu DF, Pavone KJ, Akeju O, Cassano P, Taylor N, Eikermann M, Durham K, Swee MB, Chang T, Dording C, Soskin D, Kelley J, Mischoulon D, Brown EN, Fava M. Ketamine augmentation for outpatients with treatment-resistant depression: Preliminary ev — View Citation

Ionescu DF, Swee MB, Pavone KJ, Taylor N, Akeju O, Baer L, Nyer M, Cassano P, Mischoulon D, Alpert JE, Brown EN, Nock MK, Fava M, Cusin C. Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Second — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)	Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ?50% improvement on the HAM-D28.	Weekly for total duration of 4 months