Pharmacologic Treatment Augmentation in Chronic Depression - Trial NCT06410599

Timeline & Enrollment

Primary Outcome

Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison

Summary

To enroll in this clinical trial, prospective participants must meet stringent criteria. The
 participants need to fall within the age range of 18 to 64 and exhibit chronic depression at
 therapy resistance stage 2. This stage signifies that the participants have undergone
 unsuccessful treatment with at least two different antidepressants, despite adequate dosage
 and duration. Moreover, the participants should have engaged in at least 12 sessions of
 psychotherapy without experiencing significant relief from depressive symptoms. Additionally,
 participants must demonstrate the cognitive capacity to provide informed consent.
 
 Upon expressing interest in the study and consenting to participate, individuals undergo a
 thorough screening process. This screening encompasses a comprehensive clinical interview to
 assess medical and psychiatric history, as well as various medical tests. These tests include
 physical examinations, blood draws (which may include pregnancy tests for female
 participants), and electrocardiograms (ECGs) to evaluate heart function. Following the
 screening, participants are randomly assigned to one of three different treatment groups
 (Ketamine +TAU; Ketamine+CBASP, Placebo+CBASP).
 
 The study protocol involves a combination of psychotherapeutic treatment and either ketamine
 infusions or placebo. Throughout the study period, participants are subject to regular data
 collection, including psychological assessments, blood samples, and magnetic resonance
 imaging (MRI) scans. Participants' responses to treatment, as well as any changes in symptoms
 or side effects, are closely monitored.
 
 After completing the study, participants are offered follow-up therapy as part of standard
 care. MRI scans are conducted to examine changes in brain activity associated with treatment
 response and depressive symptomatology, particularly focusing on alterations in neural
 circuitry and thought processes. Additionally, participants are encouraged to report any
 changes in medication regimen or other treatments received during the study period.

ICD-10 Classifications