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.
Trial Details
Ongoing German trial (n=60) combines ketamine and CBASP for chronic depression, comparing it with placebo plus CBASP and ketamine plus TAU. Sponsored by the University Hospital Tuebingen, the study uses MADRS to assess depressive symptoms. Secondary outcomes include evaluating effects over three months and self-reported symptoms. The trial involves adults (18-64) and has a 2-year estimated duration, with endpoint evaluation between Week 7 to Week 12.NCT Number 2019-001692-37