Pharmacologic treatment augmentation in chronic depressionrandomized, controlled, double blinded, phase II study

This double-blind, placebo-controlled, Phase II trial (n=60) of ketamine and therapy (CBASP) for chronic depression (MDD) is being conducted in Germany by the University Hospital Tuebingen.

The trial investigates the augmentation of pharmacologic treatment in chronic depression, specifically focusing on the combination of ketamine hydrochloride (Ketamin Inresa 2 ml) and Cognitive Behavioral Analysis System of Psychotherapy (CBASP). The study aims to assess the reduction in depressive symptoms, comparing the ketamine plus CBASP group with a placebo plus CBASP group and a ketamine plus Treatment as Usual (TAU) group.

The primary outcome measure involves the Montgomery–Åsberg Depression Rating Scale (MADRS) between the start of and six weeks after the end of combination treatment. Secondary objectives include evaluating the persistence of effects over three months and comparing self-reported depressive symptoms using Beck-Depression-Inventory (BDI).

The trial involves adults aged 18-64 diagnosed with chronic depression and includes a placebo group (Fresenius Kabi Deutschland GmbH Isotone E NaCL 0.9). The trial is ongoing and was authorized by the competent authority on August 14, 2019, with a favorable ethics committee opinion on February 24, 2021. The estimated duration is 2 years. The endpoint evaluation will occur between Week 7 to Week 12.

EudraCT Number 2019-001692-37 and the Sponsor’s Protocol Code ketamine_plus_CBASP.

Topic Depression
Compound Ketamine Placebo
Country Germany
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