Ketamine Infusion for Treatment-resistant Major Depressive Disorder

• ClinicalTrials.gov Identifier: NCT01582945
• Recruitment Status: Completed
• First Posted: April 23, 2012
• Results First Posted: April 20, 2017
• Last Update Posted: April 20, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Cristina Cusin, MD, Massachusetts General Hospital

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Ketamine	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: N-methyl-D-aspartate Antagonist (Ketamine) Infusion for Treatment-resistant Major Depressive Disorder With Suicidal Ideation
• Study Start Date: April 2012
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ketamine IV; Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks	Drug: Ketamine; Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Outcome Measures

Primary Outcome Measures :

1. Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28) [ Time Frame: Weekly for total duration of 4 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Depression Clinical and Research Program - MGH

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Cristina Cusin, MD; MGH Department of Psychiatry

More Information

Publications of Results:

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: Secondary Analysis of an Open-Label Study. J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.

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 evidence for two-step intravenous dose escalation. Aust N Z J Psychiatry. 2017 Jan;51(1):55-64. doi: 10.1177/0004867416631828.

• Responsible Party: Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01582945
• Other Study ID Numbers: 2010-P-002800
• First Posted: April 23, 2012
• Results First Posted: April 20, 2017
• Last Update Posted: April 20, 2017
• Last Verified: April 2017

Keywords provided by Cristina Cusin, MD, Massachusetts General Hospital:

Treatment resistant; suicidal ideation; major depressive disorder

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Suicidal Ideation; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms; Suicide; Self-Injurious Behavior; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action