Pharmacologic Treatment Augmentation in Chronic Depression (Ket+CBASP)

This randomised, controlled, double-blinded, Phase II study (n=60) investigates the pharmacological augmentation of chronic depression treatment using ketamine.

Conducted by University Hospital Tuebingen, the trial targets adults aged 18 to 64 exhibiting chronic depression at therapy resistance stage 2, despite previous unsuccessful treatment attempts with at least two antidepressants and a minimum of 12 psychotherapy sessions.

Participants are randomly assigned to one of three treatment groups: Ketamine +CBASP, Ketamine +TAU, or Placebo +CBASP. The study employs a combination of psychotherapeutic treatment and either ketamine infusions or placebo, with regular data collection including psychological assessments, blood samples, and MRI scans.

Primary outcome measures include changes in depressive symptoms assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS).

The study aims to evaluate treatment efficacy and safety, correlating changes in symptoms with various factors such as session contents, psychosocial support, and antidepressant medication. Last updated in May 2024, this trial is not yet recruiting participants.

Trial Details

Prospective participants in this clinical trial must meet strict criteria, including being aged 18 to 64 and experiencing chronic depression at therapy resistance stage 2, indicating unsuccessful treatment with two antidepressants and at least 12 psychotherapy sessions. After expressing interest and consenting, individuals undergo comprehensive screening involving medical tests such as physical exams, blood draws, and ECGs. Following screening, participants are randomly assigned to treatment groups receiving Ketamine +TAU, Ketamine+CBASP, or Placebo+CBASP. The study combines psychotherapeutic treatment with ketamine or placebo, with regular data collection including psychological assessments, blood samples, and MRI scans. After completion, participants receive standard care follow-up therapy, while MRI scans assess changes in brain activity related to treatment response and depressive symptoms. Participants are also encouraged to report any medication changes during the study.

NCT Number NCT06410599

Data attribution

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