Pharmacologic Treatment Augmentation in Chronic Depression

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 29, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2026

Conditions
Major Depressive Disorder
Interventions
DRUG

Ketamine

Two ketamine hydrochloride (Ketamin Inresa 2 ml) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Ketamine hydrochloride (Ketamin Inresa 2 ml) is applied continuously over a time span of 40 minutes with a subanesthetic dosage of 0.5 mg per kg body weight.

DRUG

Placebo

Two times placebo (Isotone E NaCL 0.9 %) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Placebo is applied continuously over a time span of 40 minutes.

BEHAVIORAL

CBASP

In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific.

BEHAVIORAL

TAU

Standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements.

Trial Locations (2)

72070

RECRUITING

Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie, Tübingen

07743

RECRUITING

Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie, Jena

All Listed Sponsors
collaborator

German Center for Mental Health

UNKNOWN

lead

University Hospital Tuebingen

OTHER

NCT06410599 - Pharmacologic Treatment Augmentation in Chronic Depression | Biotech Hunter | Biotech Hunter