Ketamine for Treatment Resistant MDD

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Diagnosed with unipolar/bipolar depression with MADRS Score>= 20

• Inadequate response to >= 3 adequate treatment trials [>=2 trials in the present episode]

• If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment

• QTc WNL

Exclusion Criteria:

• Hypersensitivity to ketamine

• Other major psychiatric diagnosis

• High suicidality

• Unstable physical illness

• S/P CVA / brain SOL

• Pregnant or breast feeding women

• Illicit drug/alcohol abuse during last year

• History of ketamine abuse